Making ACE Work for You: Importing FDA Regulated Products

Making ACE Work for You: Importing FDA Regulated Products
Office of Enforcement and Import Operations and Office of Information Systems Management ••• US Food and Drug Administration August 2017

Information and Resources for All FDA Regulated Products
Agenda Overview: ACE and FDA Commodity Specific Information Information and Resources for All FDA Regulated Products What is ACE? How ACE Works for FDA FDA Current Status Most Common CBP and FDA Rejections Common Data Errors FDA Flags FDA ACE Final Rule Changes Know the Product Being Imported Information Needed for Submission Common Reasons for Commodity Specific Entry Processing Delays Commodity Specific Resources Avoiding Delays with FDA Use the Supplemental Guide Summary Frequently Asked Questions Resources FDA Points of Contact for Imports

Overview: ACE and FDA

What is ACE? The Automated Commercial Environment is a centralized system for all transactions related to imports and exports. Filers electronically submit all information related to an inbound shipment and the government processes the transaction systematically and sends status updates.

How ACE & PREDICT Work for FDA
Industry CBP FDA Filer accesses ACE through the Automated Broker Interface, submits PGA Message Set to CBP CBP conducts a syntax validation to ensure all mandatory data is populated; if PGA Message Set is complete, CBP will send to FDA for further processing. Entries with missing data will prompt an error message back to the filer. Data is stored in and processed by OASIS, screened by PREDICT (PN screening if required) FDA generates a cargo disposition message and sends to CBP * CBP sends the message back to the filer * Data that is electronically validated may be automatically “May Proceeded” 1 2 3 4 5 Filer learns requirements and prepares entry. Filer uses purchased software to send entry data to CBP via ACE. CBP receives the entry. If all data is present and in the correct format, CBP accepts the entry. If not, CBP rejects the entry and the filer will need to make corrections. Only entries that have complete information per FDA and CBP requirements will be accepted. Once CBP accepts the entry, it will be sent to any government agency that has jurisdiction. Once it sends to FDA, FDA will either begin processing the entry or reject it back to CBP/Filer if data is invalid or incomplete. Once FDA receives a properly populated entry, it processes the data with PREDICT screening tool and stores information in the OASIS database. Depending on the accuracy of the data and risk assessment of the product, lines may be automatically may proceeded OR reviewed by FDA staff at the ports. When FDA makes an admissibility decision or requests any additional information or action, these messages are sent to CBP, and CBP sends them to the filer. Note: Once FDA has received an entry for processing, PGA updates cannot be made to FDA data unless FDA rejects the entry. If the filer notes an error or missing data in his or her transmission and FDA has not rejected the entry, the filer should contact the local FDA office where the entry was filed to see if the entry should be cancelled and refiled.

FDA Current Status 57.8M 11.2M 100 ACE became mandatory in June 2016
Final Rule issued in November 2016 FDA Supplemental Guide version 2.5 released February 2017 FDA continues to work closely with importers, brokers, and software developers to ensure understanding and compliance of the “new” ACE process FDA also continues to collaborate with CBP to troubleshoot issues and make system enhancements over 57.8M lines 11.2M entries 100 % filer participation Data as of July 7, 2017 Entry and line data updated as of July 7, 2017

FDA Current Status Automated May Proceeds have increased in ACE, and the percentage of lines requiring manual review have decreased. In 2014, only 26% of (ACS) lines were Automated May Proceeds. In 2016, (after full implementation of ACE and updates to FDA processing tools including line level release functionality), 62% of lines were Automated May Proceeds. The next two slides are being provided to show how standardized data (providing complete and correct entry information) improves FDA processing times and leads to the reduction of FDA requests for information and additional documents. Note: This data was gathered (then extrapolated) for a six month time period and due to the transactional nature of systems and associated variables, may change moving forward. Automated May Proceeds have increased in ACE, and the percentage of lines requiring manual review have decreased. In 2014, only 26% of (ACS) lines were Automated May Proceeds. In 2016, (after full implementation of ACE and updates to FDA processing tools including line level release functionality), 62% of lines were Automated May Proceeds. Bottom line: Automated May Proceed rates have increased dramatically in ACE. The percent of lines requiring manual review has decreased considerably.

FDA Current Status In ACE, FDA requests less documents.
In 2014, approximately 3% of (ACS) lines needed additional information to make an admissibility decision (Documents Required). In 2016, approximately 2% of (ACE) lines needed additional information to make an admissibility decision (Documents Required). There were approximately 28,374 fewer lines needing additional information to make an admissibility decision (Documents Required) in 2016 than in 2014. In ACE, FDA requests less documents. (Figures are for Fiscal Year) In 2014, 3.13% of (ACS) lines needed additional information to make an admissibility decision (Documents Requested). In 2016, 2.59% of (ACE) lines needed additional information to make an admissibility decision (Documents Requested). Bottom line: In ACE, FDA requests fewer documents

Most Common CBP & FDA Rejects
CBP Rejects FDA Rejects Missing or Invalid Affirmations of Compliance Invalid Food Facility Registration Number – 27% Missing or Invalid Entities Cancelled Food Facility Registration Number - 21% Missing or Invalid Unit of Measure Invalid Product Code – 15% Product Code Conflicts with Program Foreign UC/DP must be U.S. based Missing or Invalid Source Type (Country Type) Submitting UC instead of DP and vice versa Common CBP rejects (per inquiries coming to FDA ACE Support): Missing or Incorrect Affirmations of Compliance Missing or Invalid Entity -7 entities are required for food with Prior Notice -4 to 5 entities are required for all other commodities Prior Notice Lines: (1) PN Submitter (2) PN Transmitter (3) Manufacturer or Consolidator or Grower (4) Shipper (5) FDA Importer (6) Owner (7) Ultimate Consignee Non-Prior Notice Lines: (1) Manufacturer (2) Shipper (3) FDA Importer (4) Delivered to Party (5) Device Initial Importer Missing or Invalid Unit of Measure Product Code Conflicts with Program Missing or Invalid Source aka Country Type Submitting Ultimate Consignee aka Deliver to Party – Except for T & E entries, the full address of the ultimate consignee is required for all Prior Notice (food) entries. FDA Rejects November 2016-March 2017: 27% of all lines were rejected for Invalidated Food Facility Registration Numbers 21% of all lines were rejected for Cancelled Food Facility Registration Number 15% of all lines were rejected by FDA for Invalid Product Code and providing a foreign based ultimate consignee aka deliver to party since, this entity must always be U.S. based!

Common Data Errors Areas for Improvement
Must know the Intended Use Code of the product prior to transmitting entry data (foods do not require an IUC) Know required Entities and Affirmation of Compliance (AoC) Codes for commodity type Other than the few repeatable AoC codes listed in the SG, do not submit the same AoC code more than once per line Submit correct entity addresses and DUNS or FEI number Areas for Improvement: Filers and Importers will need to know what the product is and how it is intended to be used. You must know the Intended Use of the product to transmit the correct data for drugs, medical devices, radiation-emitting products, biologics and tobacco products. Foods do not require an intended use code. Knowing which entities are required for that commodity type, and knowing which affirmations of compliance are used for that commodity/intended use. Other than the few repeatable AoC codes listed in the SG, do not submit the same AoC code more than once per line. Submit the correct entity ddresses and DUNS or FEI numbers

Common Data Errors Consumer Use is different than Personal Use
Base Code 130 For Consumer Use as a Non-Food Product Base Code 100 For Personal Use as a Non-Food Product Base Code 210 For Personal Use as Human Food Consumer Use is different than Personal Use. Codes 130, 100 and 210 are used in the FDA Supplemental Guide. You should always refer to the SG, PG01 record of the specific commodity you are transmitting to determine which IUC code should be used. Definitions for the Base and Sub Codes can be found in Appendix R of the CATAIR Base Code 130 For Consumer Use as a Non-Food Product A product or material ultimately intended in its present form, with or without repackaging, for distribution to consumers in the general supply chain. Examples include finished goods such as clothing, toys, furniture, electronic products, chemical substances or mixtures such as refined gasoline, cut flowers, over-the-counter medicines, dietary supplements, and live plants and animals. Excludes human or animal food products, raw materials for processing, and medical de-vices. Base Code 100 For Personal Use as a Non-Food Product A living or non-living animal, plant, organism, product, drug, or material intended for private, noncommercial use, including products purchased for personal use through Internet commerce. Includes Medical Devices imported in limited quantities intended for the use of the person importing the device. For example, corrective glasses or personal dialysis machines. Other examples include consumer goods and drugs for personal use, animals for use as pets, plants for home gardens, or hunting trophy animals for private display. Excludes human and animal food products, animals for breeding, and products intended for distribution in the general public supply chain. Base Code 210 For Personal Use as Human Food A human food product intended for personal use in its present form. Examples include food products imported in limited quantities by travelers for personal consumption or as a gift. Excludes food products intended for distribution in the general public supply chain. Bottom line: Importers and brokers must have a thorough knowledge of FDA’s requirements

FD Flags FD1 – Indicates that the article may be subject to FDA jurisdiction, including FDA review under 801(a) of the FD&C Act. For products not subject to FDA jurisdiction, a filer can "Disclaim" product from FDA notification requirements. FD2 – Indicates that the article is under FDA jurisdiction and review of entry information by FDA under section 801(a) will take place. However, the article is not "food" for which prior notice information is required. FD3 – Indicates that the article may be subject to prior notice under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I. , e.g., the article has both food and non-food uses. FD4 – Indicates that the article is "food" for which prior notice is required under section 801(m) of the FD&C Act and 21 CFR Part1, subpart I. In 2015, CBP and FDA agreed that there would be no FD0 flag in the ACE environment. FDA has reassigned a new FD flag to HTS codes previously identified with a FD0 flag. The HTS codes have been reassigned with either a FD1, FD2, FD3, or FD4 flag. All FDA regulated articles should be transmitted to FDA for review. If there is no flag associated, the filer is still responsible for transmitting FDA regulated product information. If you believe that a HTS code is not assigned with the appropriate FD flag, please the FDA Imports Inquiry Team at

Final Rule The Final Rule for submission of information to the Automated Commercial Environment (ACE) was published in the Federal Register on November 29, 2016. Document Citation 81 FR 85854, Document Number , Docket No. FDA-2016-N-1487 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment CSMS # , Food and Drug Administration Final Rule

Final Rule Changes Optional – Line Value
Optional – Quantity and Unit of Measure Except for Radiation Emitting Products subject to a Form FDA 2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards and Prior Notice datasets Mandatory – Importer of Record contact information is required for all non-food lines • Although data elements may be optional, transmitting them may expedite processing • Document Citation 81 FR 85854, Document Number , Docket No. FDA-2016-N-1487 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment CSMS # , Food and Drug Administration Final Rule See each commodity section for requirements on submitting point of contact information.

Biologics

Submitting Biologic Entries in ACE
Know the Product Being Imported Information Needed for Submission Common Reasons for Biologic Entry Processing Delays Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry Some common reasons biologic entry processing is delayed And additional resources available for each commodity type

Know the Product Being Imported
BIO Know the Product Being Imported A Biologic Product is defined in Section 351 of the Public Health Service Act as, “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” Human cells, tissues, or cellular or tissue-based products (HCT/Ps) are defined in Section 361 of the PHS Act as “Human cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” The legal definitions of (see above)

BIO Know the Product Being Imported Examples of biologic products Blood and blood products for transfusion and/or manufacturing into other products Allergenic extracts, which are used for both diagnosis and treatment (for example, allergy shots) Vaccines Gene therapies Cellular therapies Tests to screen potential blood donors for infectious agents such as HIV HCT/Ps - for example, bone, ligaments, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, and semen or other reproductive tissue. It is important to know what is being imported. As a filer, it is essential to correctly file an entry. As an importer, knowing what you are importing and the requirements will help you provide all necessary information to your filer. Step 1 is determining that your product is definitely a biologic. This may also mean determining if your customer is importing a product that is a biologic that may not be in compliance with all U.S. regulations. Processing codes which apply to CBER regulated licensed biological products are allergens (ALG), vaccines (VAC), Xenotransplant (XEN), cell and gene therapy (CGT), blood and blood products (BLO), licensed devices (BLD) and blood derivatives (BDP). Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include, (read list above)

Information Needed for Submission Program & Processing Codes
BIO Information Needed for Submission Program & Processing Codes Program Code for biologic commodities is BIO. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Biologics BIO Allergens ALG Vaccines VAC Human Cells & Tissue HCT Xenotransplant XEN Cell & Gene Therapy CGT Blood and Blood Products BLO Licensed Devices BLD Blood Derivatives BDP Blood Bag with Anti-coagulant BBA Plasma Volume Expanders PVE WHAT is being imported or offered for import?

Information Needed for Submission Product Code Overview
BIO Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

Information Needed for Submission Product Codes
BIO Information Needed for Submission Product Codes Product code is mandatory. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code BIO - Biologic ALG - Allergens 57 BLO - Blood & Blood Products CGT - Cell and Gene Therapy HCT - Human Cells & Tissue VAC – Vaccines XEN – Xenotransplants BDP - Blood Derivatives BBA - Blood Bag with anti-coagulant BLD - Licensed Devices PVE - Plasma Volume Expanders WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

BIO Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Biologics Commodity Characteristic Description Mandatory Trade Name/Brand Name Mandatory only if one of the following government agency processing codes applies: ALG, BDP, BLD, BLO, CGT, VAC, XEN, BBA or PVE Quantity and Packaging* Optional but encouraged (if entered, the rules from the SG must be followed) PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-BIO Message Sets, and Valid base units applicable to FDA-BIO Message Sets Trade Name: * ALG, BDP, BLD, BLO, CGT, VAC or XEN government agency processing codes apply to CBER regulated licensed biological products. Trade Name/Brand Name is mandatory if it exists. If no Trade Name is available provide the proper name. Per 21CFR600.3 (k), Proper name is defined as the name designated in the product license, for use upon each package of the product. ** BBA or PVE government agency processing codes apply to drug products regulated by CBER (NDA and ANDA under 505 of the FD&C Act). Trade Name/Brand Name is mandatory if it exists for the NDA or the ANDA. If no Trade Name is available provide the proper name.

Affirmations of Compliance
BIO Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for biologics. Affirmation of Compliance requirements depend on the Intended Use Code. Intended Use Codes Import Scenario Affirmations of Compliance Biological or chemical for research and development into a pharmaceutical product – Investigational New Drugs (IND); clinical trials or other human/animal use Mandatory: IND Conditional: REG CBER-regulated Final product; ready for use. Importation of a licensed biological product. The Biologics License number (BLN) is the U.S. License Number. The Submission Tracking Number (STN) is associated with the manufacturer and a specific product and the first six digits represent the original submission tracking number. Mandatory: BLN or STN or both Conditional: REG, DLS Importation of drug regulated by CBER. Mandatory: DA, REG, (DA includes NDA and ANDAs only) Conditional: DLS Human Cells, tissues, and cellular and tissue based products (HCT/Ps) for implant, transplant, infusion, or transfer into a human recipient. The HCT affirmation should be used to indicate the HCT/Ps being importer or offered for import are in compliance with all applicable requirements of 21 CFR 1271. Mandatory: HCT (No Qualifier Needed for HCT) WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 and PG23 records.

BIO Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for biologics. Affirmation of Compliance requirements depend on the Intended Use Code. Intended Use Codes Import Scenario Affirmations of Compliance Human Cells, tissues, and cellular and tissue based products (HCT/Ps) for implant, transplant, infusion, or transfer into a human recipient. The HRN Affirmation should be used for Importation of human cells, tissues and cellular and tissue-based product where the establishment is registered with the FDA. Mandatory: HRN Conditional: HCT CBER Product sample for testing or lot release Mandatory: BLN or STN or both Conditional: REG, DLS CBER product For further manufacture of a licensed biological product under a short supply agreement (21 CFR )* Importation for personal use Bulk biological drug substance for processing into a pharmaceutical product Conditional: IND, REG, DLS Bulk drug substance for processing into a pharmaceutical product Mandatory: DA * Standard import of a biological drug or device for non-commercial distribution in government and non-government support program. Conditional: BLN, STN, DA, IND WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 and PG23 records. HOW can product compliance be verified? AoCs

BIO Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for biologics. Affirmation of Compliance requirements depend on the Intended Use Code. Optional product affirmation of compliance data: Entry Review Requested (ERR) Intended Use Codes Import Scenario Affirmations of Compliance * Import of a biological drug or device for trade show Conditional: BLN, STN, DA, IND * For reconditioning or repair of a non-food product Conditional: BLN, STN, DA, IND, HCT, HRN * Importation of non-compliant articles (including blood, blood components, Source plasma and source leukocytes) under the import for export provisions 801(d) (3), & 801(d) (4) of the FD&C Act. Mandatory: IFE (No qualifier required) Import of a biologic for non-clinical research use only, bench testing, etc. These entries could be disclaimed if the HTS code allows it. * Importation of a drug (including a biological product) or device for compassionate use/emergency use Import of US Goods Returned WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 and PG23 records. HOW can product compliance be verified? Affirmations of Compliance Note: You can use the Affirmation of Compliance code ERR (Entry Review Requested) for various reasons for example you have knowledge that the shipment has been time/temp abused, knowledge that the product contains a drug even though the customer insists it is a cosmetic, etc.

Information Needed for Submission Entities
BIO Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Delivered to Party (DP) Filer’s/Broker’s Point of Contact (PK) Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

Information Needed for Submission Origin and Arrival
BIO Information Needed for Submission Origin and Arrival Data Requirement Biologics Country of Production or Country of Source Mandatory Country of Refusal Mandatory if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

Summary Know the product being imported and associated requirements
BIO Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Common Reasons for Biologic Entry Processing Delays
Entry review processing delays occur when the requirements for submission are not understood. FDA PREDICT lookup failures: 5.27% have insufficient Affirmation of Compliance Code transmitted for biologic products. If the required affirmation of compliance codes transmitted are either not filed or incorrectly filed, FDA will need to manually review the entry and will most likely ask for documents and for any additional required data elements. Biologic products account for 5.27% of the total number of lines where FDA finds data error issues. As we are sure you know, FDA only has a limited number of investigators to conduct entry review. Once the entry reviewer determines that additional information and/or documentation is needed to accurately make an admissibility decision for a particular entry, those entries are set aside for later review which is not only a drain on resources for FDA, but also on trade. In other words, the entry will NOT receive an automatic may proceed with insufficient or inaccurate data is/or isn’t transmitted and WILL result in delays.

Additional Resources BIO
For more information about vaccines, blood & biologics, visit For more information about human cells & tissues, visit CBER approved and cleared devices can be found under the CDRH registration and listing system, visit Drug products regulated by CBER – Establishments Current Registration Site, visit

Cosmetics

Submitting Cosmetic Entries in ACE
Know the Product Being Imported Information Needed for Submission Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry And additional resources available for each commodity type

COS Know the Product Being Imported A Cosmetic is defined in the Federal Food & Cosmetic Act as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

COS Know the Product Being Imported Examples of cosmetic products Eye makeup (eye shadow, eyeliner, mascara) Bath products (shower gel, shampoo, bubble bath) Manicure and shaving products Oral hygiene Hair coloring Perfume/cologne/toilet water Hand, face and body cream/lotions Ingredients to be used to manufacture cosmetics Hair brushes and cosmetic brushes and sponges Some examples of cosmetic products include but are not limited to (list)

COS Information Needed for Submission Program & Processing Codes Program Code for all cosmetic commodities is COS. There is no Processing Code for cosmetics. WHAT is being imported or offered for import?

Information Needed for Submission Product Code
COS Information Needed for Submission Product Code FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Product code is mandatory. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code COS - Cosmetic N/A 50 or 53

COS Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Cosmetics Commodity Characteristic Description Mandatory Quantity and Packaging* Optional but encouraged (if entered, the rules from the SG must be followed) PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-COS Message Sets, and Valid base units applicable to FDA-COS Message Sets

COS Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Codes are not applicable to cosmetics. Affirmations of Compliance are optional for cosmetics. Cosmetic Registration Number (COS) Entry Review Requested (ERR) Import for Export (IFE) WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

COS Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Required Mandatory Shipper (DEQ) Required FDA Importer (FD1) Required Delivered to Party (DP) Required Filer’s/Broker’s Point of Contact (PK) Optional but encouraged Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

COS Information Needed for Submission Origin and Arrival Data Requirement Biologics Country of Production Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

COS Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

COS Additional Resources For more information about cosmetics, visit Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), visit For additional information about FDA Authority Over Cosmetics, visit

Drugs

Submitting Drug Entries in ACE
Know the Product Being Imported Information Needed for Submission Common Reasons for Drug Entry Processing Delays Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry Some common reasons for drug entry processing delays And additional resources available for each commodity type

DRU Know the Product Being Imported “Drug” is defined in the Food, Drug, and Cosmetic Act as, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]. This includes: Articles that are not active ingredients, but are labeled with a claim to “diagnose, cure, mitigate, treat, or prevent disease” The Food, Drug, and Cosmetic Act defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or articles intended to affect the structure or function of man and other animals. This definition includes products that are inherently medicinal as well as those that are labeled for therapeutic purposes or advertised for therapeutic purposes.

DRU Know the Product Being Imported Examples of drug products Active pharmaceutical ingredients (API) boric acid powder used to manufacture antiseptic Over-The-Counter (OTC) acetaminophen pain killer (analgesic Prescription Drugs (RX) Dexamisole (anti-depressant Pharmaceutical Necessities inactive ingredients, excipients, intermediates For Research Use Only not to be used with humans and may be used in animals Investigational Use Only will be used with humans or animals

DRU Information Needed for Submission Program & Processing Codes Program Code for drug commodities is DRU. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Drugs DRU Prescription PRE Over the Counter OTC Pharmaceutical Necessities, Containers, Inactive Pharmaceutical Ingredients and Excipients PHN Research and Development RND Investigational INV WHAT is being imported or offered for import?

DRU Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

DRU Information Needed for Submission Product Codes Product code is mandatory. *Subject to additional rules based on FDA Program/Processing/Product codes. See PG02 in individual chapters of the Supplemental guide. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code DRU – Drug* PRE - Prescription 54, 56, 60, 61, 62, 63, 64, 65, or 66 OTC - Over the Counter RND - Research & Development INV - Investigational PHN - Pharmaceutical Necessities 55, various codes could apply WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. There are products that may be either a food (dietary supplement) or a drug Example: Vitamin D These products must be declared to FDA. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

DRU Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Drugs Commodity Characteristic Description Mandatory Quantity and Packaging* Optional but encouraged (if entered, the rules from the SG must be followed) PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity and packaging at each level Unit of Measure codes applicable to FDA-DRU Message Sets, and Valid base units applicable to FDA-DRU Message Sets * See Appendix D of the FDA Supplemental Guide for ACE v2.5 for valid units of measure for Drugs Packaging Containers.

DRU Information Needed for Submission Intended Use Codes (IUC) and Affirmations of Compliance (AoC) IUC is mandatory for drugs. Only IUCs listed in the chart can be used for drugs. AoC requirements depend on the IUC. Intended Use Codes Import Scenario Affirmations of Compliance Prescription health or medical product for human use that is the subject of an approved new drug application, abbreviated new drug application, or biologics license application Mandatory: REG, DLS, DA Optional: PLR Importation for Personal Use For Consumer Use as a Non-Food Product – Over the Counter (OTC) Mandatory: REG, DLS Optional: DA Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a pharmaceutical product Conditional: DA Active Pharmaceutical Ingredient / Bulk Drug Substance to be used for Pharmacy Compounding Importation of a drug component (API) for use in a medical product regulated under a device (CDRH) application type (e.g., for use in a PMA/510(k) drug-device combination product) Optional: DA, LST, PM#, IDE WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DRU Information Needed for Submission Intended Use Codes (IUC) and Affirmations of Compliance (AoC) IUC is mandatory for drugs. Only IUCs listed in the chart can be used for drugs. AoC requirements depend on the IUC. Intended Use Codes Import Scenario Affirmations of Compliance Importation of a drug constituent part (drug product) for use in a medical product regulated under a device (CDRH) application type (e.g., for use in a PMA/510(k) drug-device combination product). Mandatory: REG, DLS Optional: DA, LST, PM#, IDE Chemical for research and development of a pharmaceutical product – subject of an Investigational New Drug application (IND), including Placebos Mandatory: IND Chemical for research and development of a pharmaceutical product – laboratory testing only , no human/animal use Chemical for research and development; investigational use in animals WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DRU Information Needed for Submission Intended Use Codes (IUC) and Affirmations of Compliance (AoC) IUC is mandatory for drugs. Only IUCs listed in the chart can be used for drugs. AoC requirements depend on the IUC. Intended Use Codes Import Scenario Affirmations of Compliance Finished drug or API intended for use in an in vivo bioequivalence or bioavailability study in humans that qualifies under 21 CFR for an exemption from the Part 312 requirements; or finished drug intended for use in clinical investigation in humans that qualifies for an exemption from Part 312 requirements. US Goods Returned Optional: REG, DLS, DA, IND Import for Export For Other Use: (APIs or Finished Drugs not elsewhere classified) Mandatory: REG, DLS WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DRU Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Delivered to Party (DP) Filer’s/Broker’s Point of Contact (PK) Optional but encouraged Sponsor (New) – if different than MF or FD1 (SPO) Optional Producer (Producer of API) (GD) WHO are the entities involved with the product being imported or offered for import?

DRU Information Needed for Submission Origin and Arrival Data Requirement Drugs Country of Production or Country of Source Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

DRU Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Common Reasons for Drug Entry Processing Delays
Entry review processing delays occur when the requirements for submission are not understood. FDA PREDICT lookup failures: 8.03% of Affirmation of Compliance Codes are incorrectly transmitted for drug products. Approximately 8% of data error issues are the result of either lack of or inaccurate transmission of affirmation of compliance codes. Examples include, no REG and/or DLS provided for drug products or they can’t be validated or no IND provided for an investigational drug product.

Additional Resources DRU
Drug Approvals and Databases: Guidance, Compliance, & Regulatory Information: Drug Firm Registration Lookup: DUNS Number Lookup: NDC Number Lookup: NDA/ANDA Lookup: Inactive Ingredient Lookup: Drug Approval Process: Research Use Only Labeling:

Additional Resources continued
DRU Additional Resources continued Investigational New Drugs (IND): Investigational Use Only Labeling: OTC (Nonprescription) Drugs: OTC Drug Labeling: New Drug Applications (NDA): Abbreviated New Drug Applications (ANDA): Prescription Drug Labeling:

Human and animal Food

Submitting Human and Animal Food Entries in ACE
Know the Product Being Imported Information Needed for Submission Common Reasons for Food Entry Processing Delays Additional Resources For each commodity we will emphasize the importance of’ Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry Some common reasons for food entry processing delays And additional resources available for each commodity type

FOO Know the Product Being Imported The term “food” means Articles used for food or drink for man or other animals Chewing gum Articles used for components of any such article

FOO Know the Product Being Imported Examples of food products Fruits and vegetables Seafood Bottle water Dietary supplements Pet food Animal feed Examples of human and animal food products Fresh and frozen produce – fruits and vegetables Baby food – infant formula and cereals Bottled water and energy drinks Seafood - such as aquaculture or wild caught salmon or shrimp Juice – again fruit and vegetable Canned Food – which include products such as pouched tuna, pickled vegetable and canned vegetables Dietary supplements for both humans and animals Pet Food – dry, canned or treats Animal feed such as hay, grain screening pellets and canola oil

Overview: Products Requiring Prior Notice
FOO Overview: Products Requiring Prior Notice Human and animal food products requiring Prior Notice include: Food imported for use, storage, or distribution in the United States Food transshipped through the United States to another country Food imported for future export Food for use in a Foreign Trade Zone (FTZ) Food for Trade Shows Food to be sold in Duty Free Shops

Options for Submitting Human and Animal Food Entries in ACE
Stand Alone Prior Notice Submission [PN Standalone] Food Commodity Combined Entry Submission [PN + 801(a)] Non-PN Food Commodity or PN Requirements Previously Met [Non-PN and PN Previously Met] Stand Alone Prior Notice Submission This chapter describes the data elements and their business rules for a stand-alone Prior Notice submission. This chapter is consisting of Prior Notice Submission (801m) requirements and the PE record requirements for FDA PE/PX. Food Commodity Combined Entry Submission In this scenario both 801(m) and 801(a) data elements will be submitted as a single message for the entry. Non-PN Food Commodity or PN Requirement Previously Met This chapter describes the data elements and their business rules for a 801A entry for Food, with the Government Agency Program Code = ‘FOO’, which either may not be subject to PN regulations or may have already satisfied PN data requirements. To show that the PN requirements were already satisfied, a PG14 record with the PN Conformation Number) may be included in the PG Message Set in addition to all applicable PG records described in this chapter. In this scenario 801(a) data elements may be submitted with a PG14 (PN Confirmation Number) record including the Prior Notice Confirmation Number or if the Government Processing Code is CCW or if food is withdrawn from a Foreign Trade Zone (FTZ). Prior Notice Confirmation Number in PG 14 is NOT always required. Food commodities can be broken down into the following categories using the existing Government Agency data elements available in the PG01 message Three ways to obtain Prior Notice Stand-alone prior notice submission through ACE Food commodity combined entry submission through ACE Prior Notice System Interface (PNSI) Two ways to file food entries Food commodity combined entry submission - provide 801(m) and 801(a) data elements Non-PN food commodity or food commodity including PN requirements previously met - provide prior notice confirmation number and 801(a) data elements

FOO Information Needed for Submission Program & Processing Codes Program Code for all food commodities is FOO. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG Government Agency Processing Code FDA Food FOO Natural State Food NSF Processed Food PRO Animal Food (includes pet food, medicated feed and feeds) FEE Additives and Colors ADD Dietary Supplements DSU Ceramicware or Food Contact Substance CCW WHAT is being imported or offered for import?

FOO Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

FOO Information Needed for Submission Product Codes Product code is mandatory. LACF and Acidified LACF Industry Codes: 02-39, 41, 71, & 72 with PIC: F (Aseptic) and E (Commercially Sterile) AF Industry Codes: 02-39, 41, 71, & 72 with PIC: I (Acidified) PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code FOO – Food* NSF - Natural State Food 01-46, 48, 49, 50, 52, 54, 69, 70, 71 or 72 PRO - Processed Food FEE - Animal Feed DSU - Dietary Supplement ADD - Additives and Colors CCW - Ceramicware or Food Contact Substance 52 WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

Information Needed for Submission Packaging and Condition
FOO Information Needed for Submission Packaging and Condition Data Element PN Standalone PN+801(a) Non-PN and PN Previously Met Quantity Mandatory Optional but highly encouraged Unit of Measure Mandatory if Quantity is entered Lot Number Information Mandatory for Infant formula, Acidified Foods, and LACF products PGA Line Value WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-Food Message Sets, and Valid base units applicable to FDA-Food Message Sets * See FDA Supplemental Guide for ACE v2.5 for valid units of measure for Human and Animal Food Packaging Containers.

Information Needed for Submission Intended Use Codes
FOO Information Needed for Submission Intended Use Codes Intended Use Code is not required for foods, food contact surfaces, and prior notice. If providing an Intended Use code, the following are applicable options: WHY is this product being imported or offered for import? Personal Importation FDA Definition: A personal importation is a product not for further sale or distribution into United States commerce. These products may be carried in baggage or shipped by courier or international mail. FDA webpage at CBP Definition: A human food product intended for personal use in its present form. Examples include food products imported in limited quantities by travelers for personal consumption or as a gift. Excludes food products intended for distribution in the general public supply chain. ACE ABI CATAIR Appendix R Intended Use Codes for ACE at CFSAN Regulated Products Import Scenario Intended Use Code CBP Intended Use Name For Research Use as Human Food For Research Use as an Animal Food Personal Importation For Personal Use as Human Food

FOO Information Needed for Submission Entities Entity Data Requirement PN Standalone PN+801(a) Non-PN and PN Previously Met Prior Notice Submitter (PNS) Mandatory Prior Notice Transmitter (PNT) Manufacturer (MF) or FDA Consolidator (FDC) or Grower (DFI) (Only MF allowed) Shipper (DEQ) FDA Importer (FD1) (Except for T&E entries) Ultimate Consignee (UC) Owner (DFP) Location of Goods (LG) Mandatory when the article of food/feed was refused for inadequate PN and moved under CBP Supervision Foreign Supplier Verification Program Importer (FSV) Mandatory beginning May 30, 2017 Delivered to Party (DP) Broker/Filer Point of Contact (PK) Optional but highly encouraged WHO are the entities involved with the product being imported or offered for import? Entities Manufacturer (MF) is submitted if the human or animal food is not in it’s natural state, see 21 CFR1.276(10) Grower (DFI) is submitted if the human or animal food is in it’s natural state FDA Consolidator (FDC) is submitted if the human or animal food is in it’s natural state and the grower is unknown or the article has been consolidated and the growers are unknown

Updates and Reminders FSVP
FOO Updates and Reminders FSVP FSVP Data Elements: Firm name Firm address Address Duns # Individual’s name and phone # (optional) FSVP Exemptions: Affirmations of Compliance Research and Evaluation (RNE) FSVP Exempt (FSX) CSMS message # titled DA Foreign Supplier Verification Programs (FSVP) Initial Compliance Date: For regulatory questions about FSVP (such as who is an FSVP Importer, what is an FSVP, when is my compliance date, etc. If you are not certain where the question should go, send it here and we will route it to the TAN if needed): Infographic depicting who is subject to FSVP Requirements: For technical and policy questions that are not already addressed online or internally about FSVP (and Preventive controls), the Technical Assistance Network (TAN): As a reminder when importing human and animal food, so the program code is “FOO”, and the processing code is “NSF, PRO, ADD, DSU or FEE” and the industry code is anything besides 16 for seafood or 32 for alcohol, the following FSVP related details are mandatory: FSVP importers firm name – so that is the owner or consignee of the article of food being offered for import or if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent. their address Entity role code “FSV” and their address and the DUNS # is required (or “UNK” is allowable for now) as the only acceptable unique facility identifier (UFI) outlined in the Guidance For Industry based on the regulation, but the DUNS # may not always be the only acceptable UFI. If the line item is a food and the above items are not transmitted, the entry will be rejected by CBP unless an affirmation of compliance exemption is declared. If applicable, there are two affirmation of compliance exemption codes “RNE” for research and evaluation and “FSX” if FSVP exempt or have a later compliance date. We’ve included several links here where you can ask questions and/or find answers. One of the links is for CSMS message # which posted on May 31st of this year and has a lot of really great information about FSVP and what is required at time of filing and contains links to various other resources available for additional information pertaining to FSVP. The affirmation of compliance (exemption) FSX shall not be used as an Entity Code. FSV is the appropriate Entity Code to identify a FSVP importer.

Information Needed for Submission Affirmations of Compliance
FOO Information Needed for Submission Affirmations of Compliance Required Affirmation of Compliance Codes PN Standalone PN+801(a) Non-PN and PN Previously Met PFR or CFR or GFR or FME Mandatory RNO Required for Rail or Containerized Rail Conditional CAN Required if using PG13 or if SCAT or IATA not provided VFT Required for Air, Rail, Truck, or Ocean VES Required for Ocean FCE Required for LACF and AF products SID Required for LACF and AF products VOL Required for LACF and AF products if container dimensions not provided FSX Required if applicable beginning May 30, 2017 RNE Required if applicable beginning May 30, 2017 HOW can product compliance be verified? Affirmations of Compliance Optional Affirmation of Compliance Codes (O for Optional) SFR UFR IFR TFR ORN SRN CFR GFR LFR CCC CIN ERR FAP FCC IBP IFE PKC AIN JIF SIF PN Standalone O PN+801(a) Non PN & PN Prev. Met

Information Needed for Submission Origin, Shipment, and Arrival
FOO Information Needed for Submission Origin, Shipment, and Arrival Data Element PN Standalone PN+801(a) Non-PN and PN Previously Met Country of Production or Place of Growth Mandatory Country of Shipment Country of Refusal Mandatory if refused by other country(-ies) Container Number Mandatory if containerized cargo by water, air, rail, or land Express Courier Tracking Number Mandatory for mail/express courier in lieu of AWB/BOL/Flight # Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Arrival Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries. Product Origin Country of Production is required for Non-Natural Human Food and Animal Food Country of Growth is required for All Natural State Human Food and Animal Food

FOO Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Common Reasons for Food Entry Processing Delays
Low Acid and Acidified Foods Failure to provide: FCE and SID; Container Dimensions or Volume; Lot Number Firm and/or Product incorrectly provided Again, entry review processing delays occur when the requirements for submission are not understood. For example, commercial processors who manufacture, process or pack low-acid and/or acidified foods are subject to registration requirements as well as the process filing requirements. They file with FDA and provide information including name of the firms principal place of business, each location in which processing is carried on, the processing method, and a list of foods and container dimensions processed in each location. When transmitting entry lines for these types of food, affirmation of compliance codes FCE, SID and container dimensions are required to be provided and filers need to obtain this processing information from the Importer PRIOR to transmitting! Recently it has been determined that 5.48% of all lines filed with transmission errors are low-acid and acidified food product lines and fail due to either they do not have the A of C codes FCE, SID and container dimensions transmitted or the firm and/or product does not match what was filed.

Additional Resources FOO
For more information about Human and Animal Foods, visit For more information about Registration of Food Facilities, visit For Prior Notice Q&As, visit

Medical devices

Submitting Medical Device Entries in ACE
Know the Product Being Imported Information Needed for Submission Common Reasons for Medical Device Entry Processing Delays Additional Resources For each commodity we will emphasize the importance of’ Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry Some common reasons for medical device entry processing delays And additional resources available for each commodity type

DEV Know the Product Being Imported If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and post marketing regulatory controls. A device is: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

DEV Know the Product Being Imported Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. (21 CFR 820.3(c)) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. (21 CFR (l)) Throughout the filing process, it is important to know if the medical device being imported is a component of a finished device or a finished device. For example, if a component is being imported, the filer needs to submit the country of source; if a finished device is being imported, the filer needs to submit a country of production. Additionally, some intended use codes differentiate between finished devices and components. It is important for importers to understand FDA’s definition of components and devices. Filers need to be sure they are collecting this information from the importers and considering it when submitting Country of source/production, intended use codes, and affirmations of compliance. In addition to the definition of components and finished devices, FDA has resources on their website to help determine if the product is a component or a finished device. Per the U.S. Code of Federal Regulations, Title 21, Part 820.3(c), a medical device component is: “...any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.” A component is generally a non-functioning construct or element that then undergoes further assembly and manufacture. It is part of a finished medical device, and is not offered for sale to entities aside from the finished medical device manufacturer. In other words, if your product is not separately distributed (i.e., not sold or available separately) to consumers/end users, and is only sold to the manufacturer, then it would likely be considered a medical device component (i.e., an incomplete, nonfunctioning part of the finished medical device). Component manufacturers are exempt from the Quality System regulations (per 21 CFR 820.1(a)) and registration and listing requirements (per 21 CFR (a)), unless the “components … are packaged or labeled for commercial distribution …”, in which case, the manufacturer is required to register, list, and pay the R&L fee (per the “Domestic establishments” table at the Registration and Listing webpage). Per the draft guidance entitled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, a product may be considered an accessory, if it is (1) intended for use with one or more parent devices (i.e., it has no other use and/or cannot be fitted onto another device and function, but may be a complete/functioning item) and/or (2) intended to support, supplement, and/or augment the performance of one or more parent devices (it may be sold to manufacturers, like a component, but is also marketed separately/directly to consumers/end users – spare or replacement parts, for instance). For example, a rechargeable battery that is intended to operate when paired with an automated external defibrillator (AED) supports an AED by enabling it to defibrillate. In this case, the accessory is necessary to enable the parent device to meet its intended use. Accessories are subject to the same requirements as the original device, including compliance with the Quality System Regulation in 21 CFR 820 (per 21 CFR 820.3(l), a “finished device” includes “any … accessory to a device”) as well as Registration and Listing (per the “Domestic establishments” table, any “Manufacturer of accessories or components that are packaged or labeled for commercial distribution …” is required to register, list, and pay the R&L fee). For further guidance, there is FDA's educational resources of Device Advice, and CDRH Learn for comprehensive regulatory information about medical devices.

DEV Know the Product Being Imported Examples of medical devices Tongue depressors and bedpans Myocardial and Epicardial leads Surgical lasers In vitro diagnostic test kits Reagents Diagnostic ultrasound products X-ray machines Medical devices range from simple to complex. For example tongue depressors and bedpans to programmable pacemakers, with micro-chip technology, myocardial and epicardial leads and laser surgical devices. In vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology for example glucometers and HIV and hepatitis test kits. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device, such as diagnostic ultrasound products, x-ray machines and medical lasers.

DEV Information Needed for Submission Program & Processing Codes Program Code for medical device commodities is DEV. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Medical Devices DEV Radiation Emitting Devices * RED Non-Radiation Emitting Devices NED WHAT is being imported or offered for import?

DEV Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

DEV Information Needed for Submission Product Codes Product code is mandatory. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code DEV - Medical Device NED - Non-Radiation Emitting Device 73-92 RED - Radiation-Emitting Device WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

Radiation Emitting Devices Non-radiation Emitting Devices
Information Needed for Submission Product Descriptions, Packaging and Condition Data requirements depend on whether the product is: Radiation Emitting Device Non-Radiation Emitting Device See the FDA Supplemental Guide for ACE v2.5 for valid units of measure for medical device packaging containers. Data Requirement Radiation Emitting Devices Non-radiation Emitting Devices Commodity Characteristic Description Mandatory Quantity and Packaging* (if entered, the rules from the SG must be followed) if the product requires a 2877 Optional but encouraged PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-DEV Message Sets, and Valid base units applicable to FDA-DEV Message Sets

DEV Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for medical devices. Affirmation of Compliance requirements depend on the Intended Use Code. *Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision. Intended Use Codes Import Scenario Affirmations of Compliance or UNK Standard import of device, accessories, or components regulated as a finished device Import of refurbished device Import of a reprocessed device Mandatory: DEV, DFE, LST Conditional: IRC, LWC, PM# Optional: DI * Import of a device for domestic refurbishing Domestically manufactured device that is part of a medical device convenience kit Mandatory: DDM, DFE, KIT, LST Foreign manufactured device that is Part of a medical device convenience kit Mandatory: KIT, DEV, DFE, LST Conditional: PM#, LWC; IRC WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DEV Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for medical devices. Affirmation of Compliance requirements depend on the Intended Use Code. Intended Use Codes Import Scenario Affirmations of Compliance Device constituent part for drug-device combination product Mandatory: DEV, DFE, LST Conditional: DA, IND Import of a device for charity Conditional: IRC, LWC, PM# Optional: DI Component for further manufacturing into a finished medical device Mandatory: CPT Optional: LST, PM# Device component for use in a drug-device combination product Repair of medical device and re-exportation Mandatory: IFE Conditional: DFE, LST, IRC, LWC, PM#, DDM WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DEV Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for medical devices. Affirmation of Compliance requirements depend on the Intended Use Code. *Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision. Intended Use Codes Import Scenario Affirmations of Compliance Import of research or investigational use in vitro diagnostic device * Import of a device for non-clinical use/bench testing Import of device sample for customer evaluation * Import of a medical device for clinical investigational use Mandatory: IDE Import of a device that is US goods returned for refund/overstock (to manufacturer) Mandatory: DDM, LST Conditional: DFE, IRC, LWC, PM# Optional: DI Import of device that is US goods returned for sale to a third party Mandatory: DFE, DDM, LST Conditional: IRC, LWC, PM# WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

DEV Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for medical devices. Affirmation of Compliance requirements depend on the Intended Use Code. *Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision. Intended Use Codes Import Scenario Affirmations of Compliance * Import of a single-use device for domestic reprocessing Mandatory: DDM, LST Conditional: DFE, IRC, LWC, PM# Optional: DI * Import of a multi-use device for domestic reprocessing Conditional: DDM, DFE, IRC, LST, LWC, PM# Import for Export: Import of a medical device for further processing and re-exportation Importation of a medical device or accessory for further manufacturing into an export-only medical device Mandatory: DEV, DFE, IFE, LST WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs Medical devices imported for export are NOT exempt from registration and listing requirements, only clearance/approval.

DEV Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for medical devices. Affirmation of Compliance requirements depend on the Intended Use Code. *Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision. Intended Use Codes Import Scenario Affirmations of Compliance Import for Export: Importation of a medical device component for further manufacturing into an export-only medical device Mandatory: IFE, CPT, DDM, LST * Device For Personal Use * Public Exhibition/Trade Show * Compassionate Use/Emergency device WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs Intended Use Code is for medical devices imported under FDA’s Personal Importation Policy in the RPM.

DEV Information Needed for Submission Entities FEI number is preferred and DUNS number is encouraged when FEI number is unknown. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Device Initial Importer (DII) Delivered to Party (DP) Filer’s/Broker’s Point of Contact (PK) Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

DEV Information Needed for Submission Origin and Arrival Data Requirement Medical Devices Country of Production for a finished product or Country of Source for a component Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

DEV Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Common Reasons for Medical Device Entry Processing Delays
Required Affirmation of Compliance (A of C) Codes incomplete or incorrect (LST, DEV, DFE, etc.) Firm Name does not match A of C Device Initial Importer Entity Product Code Incorrect Country Code U.S. Transmitting “UNK” As you can see medical device entries have by far the highest percent of errors, in fact almost 71% of PREDICT lookup failures are due to missing or inaccurate data transmissions. These include Affirmation of compliance codes either being not transmitted or being incomplete or incorrectly transmitted. Firm name does not match the affirmation of compliance codes provided The device initial importer entity is either not filed (is this correct or would that be rejected) or incorrectly filed The country code U.S. is used (is this only if the mfr. Is other than U.S?) Filer transmits affirmation of compliance code “UNK” instead of the “LST” and the listing number.

Additional Resources DEV
For more information about medical devices, visit For examples of accessories to medical devices, visit Device Advise, visit CDRH Learn, visit Device Registration Database, visit Premarket Approval Database , visit Product Classification Database, visit Who Must Register and List, visit The Product Classification Database in is very helpful. This is an excellent tool for importers and filers to help determine if their product meets the definition of the product described in the particular CFR citation and if so, provides the product code, product class, review panel, registration and listing requirements, clearance/approval requirements.

Tobacco

Submitting Tobacco Entries in ACE
Know the Product Being Imported Information Needed for Submission Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry And additional resources available for each commodity type

TOB Know the Product Being Imported The Federal Food, Drug, and Cosmetic Act defines “tobacco product” as “any part made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).

TOB Know the Product Being Imported Example of tobacco products Cigarettes, cigarette tobacco and roll-your-own tobacco Smokeless tobacco (e.g. snuff and chewing tobacco) Electronic cigarettes Cigars Hookah Pipe tobacco Their components and parts, but not their accessories The FDA now regulates all tobacco products, including hookah (also called water-pipe tobacco), electronic cigarettes (which use a heat source, usually powered by a battery, to turn “e-liquid,” a liquid that usually contains nicotine from tobacco and flavorings, into an aerosol that is inhaled by the user), dissolvables (sold as lozenges, strips, or sticks, and may look like candy), smokeless tobacco (two most common types are chewing tobacco and moist snuff), cigarettes, all cigars, roll-your-own tobacco, pipe tobacco, and future tobacco products that meet the statutory definition of a tobacco product.

TOB Information Needed for Submission Program & Processing Codes Program Code for tobacco commodities is TOB. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Tobacco TOB Consumer Use CSU For Further Manufacturing FFM Investigational INV WHAT is being imported or offered for import?

TOB Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

TOB Information Needed for Submission Product Codes Product code is mandatory. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code TOB - Tobacco CSU - Consumer Use 98 FFM - For further manufacturing INV - Investigational WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

TOB Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Tobacco Commodity Characteristic Description Mandatory Trade Name/Brand Name Required if the product is intended for consumer use (agency processing code CSU) Quantity and Packaging* (if entered, the rules from the SG must be followed) Optional but encouraged PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-TOB Message Sets, and Valid base units applicable to FDA-TOB Message Sets * See FDA Supplemental Guide for ACE v2.5 for valid units of measure for Tobacco Packaging Containers.

Intended Use Description
TOB Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Codes are conditional for tobacco products. Intended Use Code Intended Use Description For commercial process as non-food For Commercial Assembly as a Non-Food Product to be consumed For Research and Development as a non-Food Product - Animal or plant for biomedical research For Research and Development as a non-Food Product – All other Uses For Public Exhibition or Display as a Non-Food Product For Consumer Use as a Non- Food Product For Charitable Organization Use as Non-Food Product For re-packaging and re-labelling** WHY is this product being imported or offered for import? If Government Agency Program Code = TOB and Government Agency Processing Code = INV then one of the 180 Base Code Intended Use Codes must be supplied. ** : Although Section 905 of the FD&C Act only applies to domestic manufacturers, it’s important for enforcement purposes to know when products are being imported for repackaging or relabeling because the re-packagers / re-labelers will need to register with FDA. Under Section 905, the term “manufacture, preparation, compounding, or processing” includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user. Ref: 701(b); Section 905 of the FD&C Act (21 U.S.C. §387e)

TOB Information Needed for Submission Affirmations of Compliance Affirmations of Compliance are optional for tobacco products. Please see the FDA Supplemental Guide for ACE for applicable codes. HOW can product compliance be verified? AoCs

TOB Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Delivered to Party (DP) Independent Third Party (ITL) Conditional Laboratory or Clinical Site (LAB) Retailer/Distributor (RD) Optional Submitter (TB) Filer’s/Broker’s Point of Contact (PK) Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

TOB Information Needed for Submission Origin and Arrival Data Requirement Tobacco Country of Production or Place of Growth or Harvested or Country of Source Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

TOB Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

TOB Additional Resources For more general information about tobacco products, visit Information on FDA’s New Tobacco Rule, visit FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products, visit

Radiation Emitting Products
Making ACE Work for You: Importing FDA Regulated Products Radiation Emitting Products

Submitting Radiation Emitting Device Entries in ACE
Know the Product Being Imported Information Needed for Submission Common Reasons for Radiation Emitting Device Entry Processing Delays Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry Some common reasons radiation emitting device entry processing is delayed And additional resources available for each commodity type

RAD Know the Product Being Imported Examples of radiation emitting products Diagnostic x-ray systems Cabinet x-ray systems Microwave ovens Laser products Sunlamp products High-intensity mercury vapor discharge lamps Ultrasonic therapy products Radiation emitting products are electronic products that emit radiation are any product that contains an electronic circuit that generates any kind of radiation in an electronic product that emits radiation. A few examples of these types of products would be: Diagnostic x-ray systems and their major components, both medical x-rays and fluoroscopy Cabinet x-ray systems for example some security emit ultrasound to detect intrusion into a secure area and others emit x-rays to produce an image used for non-intrusive inspection. Microwave ovens Laser products such as medical lasers that use precisely focused light sources to treat or remove tissues or non-medical laser products such as laser pointers, bar code readers and lasers specifically designed for laser light shows. Sunlamp products and ultraviolet lamps intended for use in sunlamp products High-intensity mercury vapor discharge lamps which are a bright, long-lasting light source that are often used to light large areas such as streets or parking, gyms and sports arenas. LED/LCD and UV lamps (see Imports Inquiry Team for more info)

RAD Information Needed for Submission Program & Processing Codes Program Code for radiation emitting commodities is RAD. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Radiation Emitting Products RAD Non-Medical Radiation Emitting Products REP WHAT is being imported or offered for import?

RAD Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

RAD Information Needed for Submission Product Codes Product code is mandatory. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code RAD - Radiation-Emitting Products REP - Non-Medical Radiation-Emitting Product 94-97 WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

Radiation Emitting Product
Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Radiation Emitting Product Commodity Characteristic Description Mandatory Trade Name/Brand Name if product requires a 2877 Quantity and Packaging* (when entered, the rules from the SG must be followed) PGA Line Value Optional but highly encouraged * See the FDA Supplemental Guide for ACE v2.5 for valid units of measure for Radiation Emitting Product Packaging Containers. WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-RAD Message Sets, and Valid base units applicable to FDA-RAD Message Sets

Information Needed for Submission Intended Use Codes
RAD Information Needed for Submission Intended Use Codes Intended Use Code is mandatory for radiation emitting products. Intended Use Codes Import Scenario Veterinary Medical Use as a Non-Food Product under Controlled Distribution Military Use as a Non- Food Product Personal Use as a Non- Food Product Public Exhibition or Display as a Non-Food Product Public Safety Use as a Non-Food Product Consumer Use as a Non- Food Product Charitable Organization Use as Non-Food Product Commercial Processing as a Non-Food Product Commercial Assembly as a Non-Food Product Repair of a Non-Food Product Research and Development as a Non-Food Product Import Export Other Use WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets.

RAD Information Needed for Submission Affirmations of Compliance These Affirmations of Compliance are conditional for radiation emitting products requiring a 2877. AoC Code Description Requirement RA1, RA2, RA3, RA4, RA5, RA6 and RA7 EPRC Radiation - emitting Products. Use if FDA compliance is non-applicable. See Form FDA 2877. Conditional RB1 EPRC Radiation - emitting Products. Use if product is FDA compliant. See Form FDA 2877 (must transmit with ANC or ACC). RB2, RC1* EPRC Radiation products. Use if product is FDA compliant. See Form FDA 2877. RC2 EPRC Product Declaration C2 (FDA 2877). RD1*, RD2*, RD3 EPRC Radiation products. Use if product is non-compliant but will be re-conditioned under bond and Form FDA766. See Form FDA 2877. ACC EPRC (Electronic Product Radiation Control ) Accession Number ANC PRC Radiation - emitting Products Annual Report Accession Number HOW can product compliance be verified? AoCs The RA, RB, RC, and RD designations are the electronic version of the FDA Form 2877 and directly correspond to the boxes that are checked on the form. Some products the FDA 2877 is not required and therefore no affirmation of compliance should be submitted.

RAD Information Needed for Submission Affirmations of Compliance The following Affirmations of Compliance are optional for radiation emitting products. AoC Code Description Requirement MDL Model Number of the Product Optional ERR Entry Review Requested IFE Import For Export CCM Name of the Certified Component Manufacturer HOW can product compliance be verified? AoCs

RAD Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Delivered to Party (DP) Filer’s/Broker’s Point of Contact (PK) Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

RAD Information Needed for Submission Origin and Arrival Data Requirement Radiation Emitting Products Country of Production or Country of Source Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

RAD Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Common Reasons for Radiation Emitting Device Entry Processing Delays
No Affirmation of Compliance Codes not or incorrectly provided % FDA PREDICT lookup failures Accession Number (ACC) Annual Report Accession Number (ANC) The lack of or incorrectly transmitting the affirmation of compliance codes ACC and ANC account for 10.46% of the entry failures so if this is a commodity you ship or handle these errors could potentially cost you precious time and storage fees.

RAD Additional Resources For more general information about radiation emitting products, visit For additional information concerning Radiation Emitting Electronic Product Codes, visit

Animal Drugs & Devices

Submitting Animal Drug and Device Entries in ACE
VME Submitting Animal Drug and Device Entries in ACE Know the Product Being Imported Information Needed for Submission Additional Resources For each commodity we will emphasize the importance of Knowing what the product is that is being imported and it’s intended use Providing and or asking for the information needed prior to submission of the entry And additional resources available for each commodity type

VME Know the Product Being Imported FD&C Act defines “drug” as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals“. A “new animal drug” means any drug intended for use for animals other than man, including any drug intended for use in animal feed but some exclusions do apply. Animal/Veterinary medical devices Animal devices are defined the same as medical device for human use; however, device manufacturers who exclusively manufacture or distribute veterinary devices 1) are not required to register their establishments and list veterinary devices and 2) are not require submission of a 510(k), PMA, or any pre-market approval for devices used in veterinary medicine. However, firms that manufacture radiation emitting devices need to register their products under the radiological health regulations. FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded or adulterated.

VME Know the Product Being Imported Examples of animal drugs Penicillin G Benzathine Butorphanol Tartrate Gentamicin Sulfate Tetracycline and Monensin Examples of devices for use on animals Immobilizer Scales X-ray systems Capnography and oxygen monitors

VME Information Needed for Submission Program & Processing Codes Program Code for animal drug and device commodities is VME. The Processing Code will be determined by the commodity sub-type: PG Government Agency Code Commodity Type PG Government Agency Program Code Commodity Sub-Type PG01 - Government Agency Processing Code FDA Animal Drugs and Devices VME Animal Drugs ADR Animal Devices ADE WHAT is being imported or offered for import?

VME Information Needed for Submission Product Code Overview FDA Product Code errors are among the most common reasons for FDA Entry Rejections. Use a valid FDA Product Code per the FDA Product Code Builder. Structure of the FDA Product Code Position 1-2 3 4 5 6-7 Name Industry Code (N) Class Code (A) Sub Class Code (A or “-”) Process Identification Code – PIC Product (AN) Legend: N – Numeric; A – Alphabetic; AN - Alphanumeric WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district. Industry Code: This element is two numbers from "02" to "98.” An industry code determines the broadest area into which a product falls. Some examples are dental for all dental-related medical devices and fishery/seafood for fish and seafood products. Class Code: This element is always one letter (a-z) and is directly related to an industry. It designates the food group, source, product, use, pharmacological action, category, or animal species of the product. Class is more specific than an industry code; for example, the fishery/seafood products industry may contain classes such as crustaceans or hot-smoked fish. All products will have a Class Code. Class codes for radiation-emitting products, medical devices and in-vitro diagnostics are linked to the Product (Group) letters, see below. Subclass Code: This element is one letter (a-z) and represents the container type, method of application, use, market class or material the product is being packaged in. The subclass should specify the primary material which contacts and/or holds the product. Medical devices do not have subclass codes and are represented by a hyphen. Process Indicator Code (PIC): This element is one letter (a-z) and describes the process, storage or dosage form depending on the type of product. When in doubt, you may wish to contact the manufacturer for processing information. Medical devices, cosmetics, and some animal use products do not have a PIC and are represented by a hyphen. Product (Group): This element is two characters in length and may contain either letters or numbers. This element relates directly to a particular industry/class combination. This element identifies the specific product. For medical devices, the product (group) element is two letters and when used in conjunction with the class element, identifies a specific medical device.

VME Information Needed for Submission Product Codes Product code is mandatory. *Subject to additional rules based on FDA Program/Processing/Product codes. See PG02 in individual chapters of the Supplemental guide. PG01: Program Code & Commodity PG01: Processing Code & Commodity Subtype PG02: Industry Code VME - Animal Drug or Device* ADR - Animal Drug 54, 56, 60, 61, 62, 63, 64, 65, 66 or 67 ADE - Animal Device 68 WHAT is being imported or offered for import? Emphasis: The FDA Supplemental Guide identifies Industry Codes associated with Program and Processing Code combinations. The Product Code Builder Tool and Tutorial can be used to “build” the product code. Product Code Training Product Code training is a separate curriculum from ACE training. To request Product Code training, reach out to your local import district.

Animal Drugs and Devices
VME Information Needed for Submission Product Descriptions, Packaging and Condition Data Requirement Animal Drugs and Devices Commodity Characteristic Description Mandatory Quantity and Packaging* (if entered, the rules from the SG must be followed) Optional but encouraged PGA Line Value Optional but highly encouraged WHAT is being imported or offered for import? See the latest FDA Supplemental Guide for ACE for: Examples of how to transmit quantity Unit of Measure codes applicable to FDA-VME Message Sets, and Valid base units applicable to FDA-VME Message Sets * See FDA Supplemental Guide for ACE v2.5 for valid units of measure for Animal Drug and Device Packaging Containers.

VME Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for animal drugs (VME/ADR). Affirmation of Compliance requirements depend on the Intended Use Code. Intended Use Codes Import Scenario Affirmations of Compliance Drug subject of a new animal drug application, conditionally approved application, or Index listing Mandatory: REG, NDC, and VAN, or VNA Optional: VFL, VFD Importation for Personal Use Active Pharmaceutical Ingredient / Bulk Drug Substance to be used for Pharmacy Compounding Mandatory: REG, NDC Active Pharmaceutical Ingredient / Bulk Drug Substance used to be further manufactured into a finished drug subject of a new animal drug application, conditionally approved application, or Index listing WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

VME Information Needed for Submission Intended Use Codes and Affirmations of Compliance Intended Use Code is mandatory for animal drugs (VME/ADR). Affirmation of Compliance requirements depend on the Intended Use Code. Intended Use Codes Import Scenario Affirmations of Compliance For research and development in a pharmaceutical product – clinical investigations in animals (INAD) Mandatory: VIN For research and development in a pharmaceutical product – for tests in-vitro or in laboratory research animals. Optional: VIN US Goods Returned Import for Export For Other Use: (APIs or Finished Drugs not elsewhere classified) Mandatory: REG, NDC Optional: VAN, VNA, VFL, VFD WHY is this product being imported or offered for import? Intended Use Codes can only be used with certain processing codes. Please refer to the latest Supplemental Guide PG01 message sets. HOW can product compliance be verified? AoCs

VME Information Needed for Submission Entities DUNS and FEI are optional, but encouraged. Entity Role (Code) Entity Name Entity Address Individual Name, Tel# and Manufacturer (MF) Mandatory Shipper (DEQ) FDA Importer (FD1) Delivered to Party (DP) Producer (GD) Optional Filer’s/Broker’s Point of Contact (PK) Optional but encouraged WHO are the entities involved with the product being imported or offered for import?

VME Information Needed for Submission Origin and Arrival Data Requirement Animal Drugs and Devices Country of Production or Country of Source Mandatory Country of Refusal if refused by other country(-ies) Anticipated Arrival Date Anticipated Arrival Time Anticipated Port of Entry Optional WHERE is the product’s origin? WHERE is the product arriving? WHEN is the product arriving? Providing correct and accurate information leads to more efficient processing and system-based releases Expedite FDA Review or Processing: indicates that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does indicate that the entry will receive priority over other entries.

VME Summary Know the product being imported and associated requirements Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer NOTE: FDA will not be able to process an entry without this information. You can help expedite FDA’s review of your imported product(s) by initially providing accurate and complete information and by responding quickly to requests from FDA for additional documents or information. Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

VME Additional Resources For more general information about animal drug and device products, visit

INFORMATION and RESOURCES for All FDA Regulated Products
Making ACE Work for You: Importing FDA Regulated Products INFORMATION and RESOURCES for All FDA Regulated Products

Avoiding Delays with FDA
Delays occur when: Inaccurate information such as incorrect product code are submitted Intended Use Code qualifier “UNK” (Unknown) To expedite FDA review: All information provided should be complete and accurate Provide conditional data elements if applicable to the product being declared Provide optional data elements such as: FEI and/or DUNS Quantity and Unit of Measure Emphasis “Expedite FDA Review” means that by providing this information the system and/or entry reviewer will have the needed data elements to complete their review in an efficient and timely manner. It does not indicate that the entry will receive priority over other entries. UNK doesn’t give the entry reviewer the information they need to determine if the product is admissible Submitting FEI/DUNS along with the correct entity name and address provides more data fro FDA to verify firm information. Affirmation of Compliance If there are duplicate affirmation of compliance submitted for a single line, it will cause it to be rejected. Conditional Data Elements For example, if the product requires premarket clearance (510(k)), then PM# must be provided. For example, if the product is glasses, then Device Impact Resistance Lens Certification (IRC) must be provided. Ensuring that all data elements provided are accurate and valid may expedite review. Example 1) Any particular registrations, listings, and/or approvals transmitted need to be specific to the entity that is required to meet the regulation. For example if you transmit the DEV for entity A (Manufacturer) and the listing for entity B (Consignee), but the regulation specifies that that manufacturer needs to be registered and listed, then you may experience delays as the information will not match what is in the internal FDA databases. Example 2) Transmitting FEI or DUNs, depending on commodity, is always preferred, and when you transmit name and address be accurate and consistent. When the name and address of an entity are transmitted differently the system may view them as different firms. Any positive history associated to past shipments will be lost on the newly created firm. This could lead to delays as firms that are new to FDA shipments are viewed to be riskier as we have no past good history to reference.

Use the FDA Supplemental Guide
Review each of the PG records until all required information is understood and has been provided by the importer Each section identifies: mandatory, optional, and conditional data elements codes and code descriptions length/class (syntax) for data element types Follow any instructions provided by your software vendor to ensure all data elements are entered for transmission. Emphasis: The FDA Supplemental Guide is a technical document for how data must be sent to FDA and is a great resource for all ACE users. The FDA Supplemental Guide identifies important information such as mandatory, optional, and conditional data elements; codes and code descriptions; and length/class (syntax) for data element types Order of PG records entered will depend on the users software

Understand the data elements Provided correct and accurate information Give Entry Filers the information they need Obtain all necessary information from the Importer Emphasis FDA goal is to facilitate compliant trade Correct and accurate information leads to more efficient processing and system-based releases

Frequently Asked Question
Q: If I transmit an FDA entry, does ACE allow me to correct the data if I realize I made a mistake? A: When CBP receives an entry, it will automatically send the entry to FDA to process in real time if the entry is within five days of arrival. Unless CBP or FDA rejected the entry, no corrections can be made. If CBP or FDA did reject your entry, work with your ABI representative to send a correction. You may be able to reach out to the local port/FDA district to provide correct information and discuss a possible resolution. Note: Even if PGA update is accepted by the ACE system, it does not affect the original record accepted by FDA.

Q: When does FDA receive the entry data from CBP? I have had an “FDA Review Message” for several days. A: Once the entry is accepted by CBP, CBP sends out a generic message that says “DATA UNDER PGA REVIEW.” This is not a confirmation that the data was sent to FDA. CBP will only send the entry to FDA, if the transmitted arrival date is within five days. If it is more than five days out, CBP will wait until it is within that timeframe to send it to FDA. If it is within five days of arrival and you have not received any FDA response within your usual turnaround time, contact FDA’s ACE Help Desk at and your CBP Client Representative.

Q: Does FDA prefer DUNS or FEI numbers for entity identification codes (PG19)? A: FEI and DUNS are optional, but encouraged. Note: As of 5/30/2017, the DUNS will be required for the FSVP importer for each line entry of food, unless they are subject to exemption and/or modified requirements. For additional information, visit FEI and DUNS are optional, but encouraged. For most entities FDA does not have a preference. Do note however that for FSVP Importers of Human and Animal Foods the DUNS number will be required as of 5/30/17 unless they are subject to exemption and/or modified requirements.

Frequently Asked Questions
Q: Is the Drug Registration number an FEI number? A: The Drug Registration Number (REG) is the 9-digit DUNS number the firm has on file with FDA Center for Drugs, Evaluation, and Research (CDER) Drug Registration (eDRLS). Only those DUNS numbers on file with eDRLS are Drug Registration Numbers (REG). These can be found at on the Drug Firm Registration Lookup webpage:

Q: Why can’t I see the status of my entry in ITACS? Why does it say “FDA entry status information is not available pending receipt of conveyance arrival notification” when the shipment has arrived? A: CBP is not consistently sending arrival notifications to FDA upon arrival of a shipment. Without receipt of that notification, ITACS will display the above message. This does not affect the ability to submit documents, submit availability information, or FDA’s ability to review the entry. Reference: CSMS #

Q: What are the lessons learned for how ACE changed filing for FDA? A: Communicate early and often about FDA requirements. (Importer, Broker, and Software Vendor). Delays and rejects occur when inaccurate information is provided, such as invalid product code or an unknown intended use code. Use FDA as a resource. Attend webinars or request a training session. We are here to help.

Frequently Asked Questions
Q: Is “UNK” (Unknown) still allowed as an Intended Use Code? A: UNK is still allowed as an Intended Use Code when the IUC is mandatory. If “UNK” is declared, CBP will not reject the entry if Affirmations of Compliance are not provided. FDA highly encourages the transmission of complete data, including the correct Intended Use Code and Affirmations of Compliance. Refer to the FDA Supplemental Guide for a full list of requirements based on the import scenario. UNK should only be used if information is not able to be obtained. Utilizing this code may lead to manual reviews and delayed processing by FDA. UNK is still allowed as an Intended Use Code when the Intended Use Code is mandatory. This will allow for transmission without required affirmations of compliance and may lead to delays and processing.

Resources CSMS # , Multiple FDA Lines are Allowed on One Tariff Line CSMS # , FDA ACE Entries: Common Errors CSMS # , FDA ACE Reject Document Posted to FDA.gov CSMS # , Multiple FDA Lines are Allowed on One Tariff Line CSMS # , FDA ACE Entries: Common Errors CSMS # , FDA ACE Reject Document Posted to FDA.gov

Resources Available Online
FDA ACE Affirmations of Compliance and Affirmations of Compliance Quick Reference at FDA ACE/ITDS Webpage (including FDA Supplemental Guide) at FDA ACE/ITDS DUNS Portal at and FDA Guide at Product Code Builder Tool and Tutorial at For more information about FDA’s Import Program, visit For information about ACE Quantity Data Instructions, visit Affirmation of Compliance Codes

Resources Contact the FDA Imports Inquiry Team for questions regarding FDA import operations and policy, product coding, FD flags associated with HTS codes, entry declaration requirements for determining admissibility, if a product is regulated by FDA and other general import questions

Resources Contact FDA ACE Support Center for technical questions related to the FDA Supplemental Guide, required data elements, ACE entries, rejects, and errors. (domestic toll-free) (local or international) CSMS # : The ACE Support Center operates from 6 a.m. to 10 p.m. EST seven days per week. Always keep your CBP Client Representative on all ACE-related traffic

FDA Points of Contact for Imports
FDA Unit Contact Information Areas of Focus ACE Support Center Toll Free: Local/International: Technical issues related to the FDA supplemental guide, required data elements, and general ACE submission questions, including entry submissions rejected by FDA. FDA Imports Inquiry General questions regarding FDA import operations and policy, including product classification (program, processing, product and HTS codes) and declaration Local FDA Office First-line support for product coding and entry-specific questions, including working through the FDA entry admissibility process, once the entry is successfully transmitted to FDA and accepted Division of Food Defense Targeting General questions regarding Prior Notice for food shipments

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