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Www.gray-robinson.com ProExport Colombia Trade Training Seminar Series May 2012 U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics.

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Presentation on theme: "Www.gray-robinson.com ProExport Colombia Trade Training Seminar Series May 2012 U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics."— Presentation transcript:

1 www.gray-robinson.com ProExport Colombia Trade Training Seminar Series May 2012 U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics Presented by: Peter Quinter & Melissa Groisman Customs and International Trade Law Group, GrayRobinson Law Firm, Miami, Florida

2 www.gray-robinson.com 2 Agenda FDA Laws and Regulations FDA Import Process FDA Detentions (DWPE) and Refusals FDA Import Alerts U.S. Customs Liquidated Damages Medical Devices Cosmetics Food

3 www.gray-robinson.com 3

4 4 Detention Process The Food, Drug, and Cosmetic Act authorizes the FDA to detain a regulated product that appears to be out of compliance. The FDA District Office will then issue a "Notice of FDA Action specifying the nature of the violation to the owner or importer.

5 www.gray-robinson.com 5 Detention Without Physical Examination (DWPE) Detention without physical examination, is appropriate when there exists a history of the importation of violative products, or products that may appear violative Detention without physical examination properly places the responsibility for ensuring compliance with the law on the importer

6 www.gray-robinson.com 6 Notice of FDA Action #1 Products that appear (from examination or otherwise) to be violative may be detained and ultimately refused entry into the U.S. Detention is permissible without actual observation of a product or its labeling.

7 www.gray-robinson.com 7 Informal Hearing The owner or importer is entitled to an informal hearing in order to provide testimony regarding the admissibility of the product. "You have the right to provide oral or written testimony to the FDA, regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance."

8 www.gray-robinson.com 8 Question The U.S. importer has the right to provide oral or written testimony to the FDA regarding the admissibility of the article(s) or the manner in which the article(s) can be brought into compliance True or false?

9 www.gray-robinson.com 9 Conditional Release 19 C.F.R. 141.113 - Food, drugs, devices, and cosmetics For purposes of determining the admissibility of any food, drug, device, or cosmetic, the release from CBP custody of any such product will be deemed conditional. The conditional release period will terminate upon the earliest occurring of the following events: 1.The date that FDA issues a notice of refusal of admission; 2.The date that FDA issues a notice that the merchandise may proceed; or 3.Upon the end of the 30-day period following the date of release.

10 www.gray-robinson.com 10 Notice to Redeliver "A request has been made to Customs to order redeliver for all the above product(s), in accordance with 19 CFR 141.113, which were conditionally released to you under terms of the entry bond. Failure to redeliver into Customs custody will result in a claim for liquidated damages under the provisions of the entry bond"

11 www.gray-robinson.com 11 Entry Bond - Agreement to Redeliver Merchandise § 113.62 Basic importation and entry bond conditions A bond for basic importation and entry shall contain the conditions listed in this section and may be either a single entry or a continuous bond. (d) Agreement to Redeliver Merchandise. If merchandise is released conditionally from Customs custody to the principal before all required evidence is produced, before its quantity and value are determined, or before its right of admission into the United States is determined, the principal agrees to redeliver timely, on demand by Customs, the merchandise released if it: (1) Fails to comply with the laws or regulations governing admission into the United States; (2) Must be examined, inspected, or appraised as required by 19 U.S.C. 1499; or (3) Must be marked with the country of origin as required by law or regulation. It is understood that any demand for redelivery will be made no later than 30 days after the date that the merchandise was released or 30 days after the end of the conditional release period (whichever is later). (See §§ 141.113(4 12.73(b)(2), and 12.80 of this chapter.)

12 www.gray-robinson.com 12 2nd Notice of FDA Action If the owner fails to submit evidence that the product is in compliance or fails to submit a plan to bring the product into compliance, FDA will issue another "Notice of FDA Action Refusing admission of the product.

13 www.gray-robinson.com 13 Final Notice FDA Action Subject: NO LOCATION RECEIVED "You have been previously notified that this shipment is to be held intact for FDA examination and/or sampling. You have not advised us of the status or location of the lot represented by the referenced entry number. A written release from FDA is required before moving your goods in domestic commerce".

14 www.gray-robinson.com 14 Notice of Refusal The following products are subject to refusal pursuant to the Federal Food Drug and Cosmetic Act in that they appear to be adulterated misbranded or otherwise in violation.

15 www.gray-robinson.com 15 Refusal The product then has to be exported or destroyed within 90 days otherwise subject to Liquidated Damages. Failure to do so may result in destruction of the products. Distribution of the products may result in their seizure and/or injunction or criminal prosecution of persons responsible for their distribution.

16 www.gray-robinson.com 16 Import Alert Import Alert # 12-10, May 25, 2012 (Cheese due to microbiological contamination) Import Alert #53-06, May 25, 2012 (cosmetics containing illegal colors)ished Date: 8/9/2010 Green List v. Red List

17 www.gray-robinson.com 17 Import Alert Example Import Alert # 16-81 Published Date: 05/13/2010 Type: DWPE (Detention Without Physical Examination) Import Alert Name: "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella" Reason for Alert: Division of Import Operations and Policy has received recommendations from districts for detention without physical examination of seafood products due to Salmonella contamination from specific manufacturers/shippers. This import alert has been developed for seafood products from firms/countries which do not readily fit into previously existing import alerts.

18 www.gray-robinson.com 18 Removal from Import Alert List FDA's Regulatory Procedures Manual –Ch. 9 - Import Operations And Actions 9-6 Detention without Physical Examination (DWPE) –http://www.fda.gov/ICECI/ComplianceManu als/RegulatoryProceduresManual/ucm1792 71.htmhttp://www.fda.gov/ICECI/ComplianceManu als/RegulatoryProceduresManual/ucm1792 71.htm

19 www.gray-robinson.com 19 Removal from Import Alert List FDA's Regulatory Procedures Manual provides guidance to those who wish to get off the Import Alert list. Generally, one would need: –A minimum of five consecutive non-violative commercial shipments must enter the U.S., –At least one of the five non-violative entries should be audited by the FDA to ensure compliance. –The five shipments must be over a reasonable time period, not one day. –A Petition must be filed with the FDA requesting that the importer be removed from the automatic detention list.

20 www.gray-robinson.com 20 Entry Bond - Consequence of Default § 113.62 Basic importation and entry bond conditions. –(m) Consequence of default. (1) If the principal defaults on agreements in this condition... the obligors agree to pay liquidated damages equal to the value of the merchandise involved in the default, or three times the value of the merchandise involved in the default if the merchandise is restricted or prohibited merchandise...

21 www.gray-robinson.com 21 CBP Form 301 Customs Bond

22 www.gray-robinson.com 22 Liquidated Damages Claim In accordance with 19 C.F.R. 141.113 –Redelivery Notice (date) –Redelivery Required (date) –"Described merchandise not redelivered into Customs custody after refused admission by the FDA" –"Failure to comply with a demand for redelivery... will result in the assessment of liquidated damages equal to three times the value of the merchandise..."

23 www.gray-robinson.com 23 Liquidated Damage Claim The provisions of 21 C.F.R. 1.97 require that Customs and FDA agree about the amount to cancel the claim for liquidated damages. All Petitions for relief received by Customs in FDA cases must be referred to FDA for recommendation. With few exceptions, Customs must follow the recommendation of FDA.

24 www.gray-robinson.com 24 Cosmetic Labeling It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to FDA action. Some of the ways a cosmetic can become misbranded are: –labeling is false or misleading –label fails to provide required information –required label information is not properly displayed

25 www.gray-robinson.com 25 Labeling Terms Labeling. This term refers to all labels and other written, printed, or graphic matter on or accompanying a product Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale Information Panel. Generally, this term refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. The information must be prominently and conspicuously displayed.

26 www.gray-robinson.com 26 Required Label Information An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure The following information must appear on an information panel. Name and place of business. This may be the manufacturer, packer, or distributor. Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly. Warning and caution statements. Cosmetics that may be hazardous to consumers must bear appropriate label warnings. Flammable cosmetics are an example. Ingredients. If the product is marketed on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance.

27 www.gray-robinson.com 27 All required labeling information must be in English It is not permitted to label cosmetics "FDA Approved. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. False or misleading statements on labeling make a cosmetic misbranded.

28 www.gray-robinson.com 28 Anti-Aging Creams Import Alert # 66-38 Published Date: 03/27/2012 "Skin Care Products Labeled As Anti-Aging Creams" There are numerous skin care products on the market with exaggerated "anti aging" claims which cause the products to be unapproved new drugs. Examples of such claims are that the products "counteract," "retard," or "control" the aging process. Claims that the product will "rejuvenate," "repair," or "restructure" the skin may also be drug claims.

29 www.gray-robinson.com 29 Voluntary Cosmetic Registration Program FDA Form 2511 - Registration of Cosmetic Product Establishment FDA Form FDA 2512 - Cosmetic Product Ingredient Statement (CPIS)

30 www.gray-robinson.com 30 What is a Medical Device? The term "device" means an instrument, apparatus, implement, machine, implant, or other similar or related article…which is: –recognized in the official National Formulary, or the United States Pharmacopeia, 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….

31 www.gray-robinson.com 31 Which of the following products is NOT a medical device? 1.Dental Floss 2.Lipstick 3.Eyeglasses 4.Pacemaker

32 www.gray-robinson.com 32 What is a Medical Device? Examples of Medical Devices: Pacemakers Contact Lenses Hearing Aids Dental Floss Thermometer

33 www.gray-robinson.com 33 Federal Food, Drug and Cosmetic Act Imported medical devices must fully comply with the Act before the device is released by U.S. Customs into the United States.

34 www.gray-robinson.com 34 Medical Device Import Alert Import Alert # 89-16 Published Date: 03/13/2012 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection The FDA often conducts establishment inspections of foreign manufacturers who produce FDA-regulated articles intended for sale in the US. As part of this inspection process, FDA may contact the foreign manufacturer and schedule the establishment inspection. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of an FDA inspection of the foreign facility, it will be assumed that the methods and controls used for the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility do not conform to the U.S. requirements, and that the devices manufactured at that facility are considered to be adulterated. They will be refused entry into the United States.

35 www.gray-robinson.com 35 Checklist To Import Medical Devices Premarket Notification (510(k)), unless exempt, or Premarket Approval (PMA) Establishment Registration on Form FDA-2891 Device Listing on Form FDA-2892 Quality System Regulation (QSR) (sometimes referred to as good manufacturing practices or GMPs) Labeling Requirements U.S. Designated Agent (for imported devices)

36 www.gray-robinson.com 36 Medical Devices Classes The class to which your device is assigned determines, among other things, the type of premarket submission or application required for FDA clearance to sell the device.

37 www.gray-robinson.com 37 Medical Devices Classes CLASS I most are exempt from Premarket Notification CLASS II most require a Premarket Notification Most Class I devices and some Class II devices are exempt from 510(k) submission. A list of exempt devices is located at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm CLASS III those that support or sustain human life, most require a Premarket Approval (PMA)

38 www.gray-robinson.com 38 DUE DILIGENCE Does the foreign manufacturer, and initial importer or distributor have a current Establishment Registration? Check FDA Website: http://www.accessdata.fda.gov/scripts/cd er/drls/default.cfm

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40 www.gray-robinson.com 40 DUE DILIGENCE -- U.S. Agent Cualquier establecimiento extranjero que se dedica a la producción, preparación, distribución, combinación o procesamiento de dispositivos importados a los Estados Unidos debe identificar a un agente en Estados Unidos (agente estadounidense) para tal establecimiento. Information on U.S. Agents can be found at (en español): http://www.fda.gov/MedicalDevices/DeviceRegulatio nandGuidance/HowtoMarketYourDevice/Registroylis tadodedispositivos/ucm257177.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulatio nandGuidance/HowtoMarketYourDevice/Registroylis tadodedispositivos/ucm257177.htm

41 www.gray-robinson.com 41 Responsabilidades de un agente estadounidense El agente estadounidense debe, ya sea residir en EE.UU. o contar con un espacio comercial en EE.UU. El agente estadounidense no puede utilizar una casilla de correo postal como dirección. El agente estadounidense no puede utilizar simplemente un servicio de respuesta. Deben estar disponibles para responder llamadas telefónicas o contar con un empleado disponible para responder llamados telefónicos durante el horario comercial normal. Las responsabilidades del agente estadounidense son limitadas e incluyen: asesorar a la FDA en comunicaciones con el establecimiento extranjero, responder preguntas relacionadas con los dispositivos de establecimiento extranjeros que son importados u ofrecidos para importación a los Estados Unidos. asesorar a la FDA en la coordinación de inspecciones a los establecimientos extranjeros y si la FDA no puede contactar al establecimiento extranjero directa o rápidamente, la FDA puede suministrar información o documentos al agente estadounidense y tal acción será considerada equivalente a proporcionar la misma información o documentos al establecimiento extranjero

42 www.gray-robinson.com 42 Questions

43 www.gray-robinson.com ProExport Colombia Trade Training Seminar Series May 2012 U.S. Customs and U.S. FDA Import Requirements for Medical Devices & Cosmetics Presented by: Peter Quinter & Melissa Groisman Customs and International Trade Law Group, GrayRobinson Law Firm, Miami, Florida


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