1. Establishment Registration and Device Listing Rod Perez, M.S.E. Consumer Safety Officer Division of Small Manufacturers, International and Consumer Assistance Western Canada 2009

2. Topics Establishment RegistrationEstablishment Registration Device ListingDevice Listing

3. What is Establishment Registration? Process which provides the FDA with the location of medical device manufacturing facilities and importersProcess which provides the FDA with the location of medical device manufacturing facilities and importers Required for establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United StatesRequired for establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States Part of General Controls for all medical devicesPart of General Controls for all medical devices Regulations are provided in 21 CFR 807Regulations are provided in 21 CFR 80721 CFR 80721 CFR 807

4. Definitions ESTABLISHMENT Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distributionESTABLISHMENT Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution OWNER/OPERATOR The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishmentOWNER/OPERATOR The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment

5. Background Effective October 1, 2007, all registration and listing information must be submitted electronicallyEffective October 1, 2007, all registration and listing information must be submitted electronically All annual registrations must take place between October 1 and December 31 of each yearAll annual registrations must take place between October 1 and December 31 of each year There is a user fee for establishment registration (initial and annual) for most establishment typesThere is a user fee for establishment registration (initial and annual) for most establishment types

6. Waivers Waivers to the electronic submission requirement can be requested in writing and granted “because electronic R&L is not reasonable…”Waivers to the electronic submission requirement can be requested in writing and granted “because electronic R&L is not reasonable…” FDA does not anticipate there will be many instances in which electronic submission of R&L is not reasonableFDA does not anticipate there will be many instances in which electronic submission of R&L is not reasonable Still responsible for any feeStill responsible for any fee

7. User Fees $2,008 USD in FY 10 (October 2009- September 2010)$2,008 USD in FY 10 (October 2009- September 2010) No reduction for small businesses or other groupsNo reduction for small businesses or other groups Paid by:Paid by: –Device manufacturers –Contract sterilizers and manufacturers if they put into commercial distributionif they put into commercial distribution –Single use device reprocessors –Specification developers

8. If You are Required to Pay the User Fee: First visit the Device Facility User Fee website to create a medical device facility user fee account and pay the fee:First visit the Device Facility User Fee website to create a medical device facility user fee account and pay the fee:Device Facility User Fee websiteDevice Facility User Fee website https://fdasfinapp8.fda.gov/OA_HTML/furls.jsp Once you make payment and receive confirmation numbers for your payment (PIN/PCN), you can proceed to the FURLS website to complete your registration and listing requirements:Once you make payment and receive confirmation numbers for your payment (PIN/PCN), you can proceed to the FURLS website to complete your registration and listing requirements: https://www.access.fda.gov/oaa

9. How to Pay User Fees Electronic payment by credit card and Automated Clearing House (ACH) electronic checkElectronic payment by credit card and Automated Clearing House (ACH) electronic check Payment by mail with check drawn on a U.S. Bank (to lock box)Payment by mail with check drawn on a U.S. Bank (to lock box) Wire transfer in U.S. funds for foreign establishmentsWire transfer in U.S. funds for foreign establishments Reminder: Can take up to 2 weeks for CDRH to be notified of payment by OFMReminder: Can take up to 2 weeks for CDRH to be notified of payment by OFM

10. Who Must Register? Manufacturers (foreign and domestic)Manufacturers (foreign and domestic) Contract manufacturers and sterilizers (If they put into commercial distribution)Contract manufacturers and sterilizers (If they put into commercial distribution) Initial distributorsInitial distributors Specification developersSpecification developers Repackagers or relabelersRepackagers or relabelers Reprocessors of Single-Use DevicesReprocessors of Single-Use Devices

11. Who Must Register? RemanufacturersRemanufacturers U.S. manufacturers of export-only devicesU.S. manufacturers of export-only devices Manufacturers of components or accessories of ready-to-be-used devicesManufacturers of components or accessories of ready-to-be-used devices Foreign dental and optical laboratoriesForeign dental and optical laboratories

12. Who Does Not Have to Register? Wholesale distributors of devices who do not manufacturer, repackage, process or relabel a deviceWholesale distributors of devices who do not manufacturer, repackage, process or relabel a device Any person importing a device that is for their personal use and not for commercial distributionAny person importing a device that is for their personal use and not for commercial distribution Refurbishers and domestic distributorsRefurbishers and domestic distributors

13. When to Submit Registration Information? Within 30 days after beginning operation (initial registration)Within 30 days after beginning operation (initial registration) Within 30 days after a changeWithin 30 days after a change Review and submit annually between October 1 and December 31 of each yearReview and submit annually between October 1 and December 31 of each year

14. Requirements for Foreign Establishments Same annual requirementsSame annual requirements Must notify FDA of initial registration prior to exporting to the U.S.Must notify FDA of initial registration prior to exporting to the U.S. Must submit U.S. Agent informationMust submit U.S. Agent information Identify known initial distributor (by their registration number) for each listingIdentify known initial distributor (by their registration number) for each listing

15. U.S. Agent Requirements All foreign establishments must notify FDA of the name, business name, address, phone number, and e-mail address of their U.S. AgentAll foreign establishments must notify FDA of the name, business name, address, phone number, and e-mail address of their U.S. Agent Only one U.S. Agent per establishmentOnly one U.S. Agent per establishment The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S.The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S.

16. Responsibilities of the U.S. Agent Assisting FDA in communications with the foreign establishmentAssisting FDA in communications with the foreign establishment Responding to questions concerning the foreign establishment's products being imported into the U.S.Responding to questions concerning the foreign establishment's products being imported into the U.S. Assisting FDA in scheduling inspections of the foreign establishmentAssisting FDA in scheduling inspections of the foreign establishment May act as Official CorrespondentMay act as Official Correspondent

17. What is a Medical Device Listing? The process which requires most medical device establishments to register with FDA to also identify those devices which they have in commercial distribution (including devices produced exclusively for export)The process which requires most medical device establishments to register with FDA to also identify those devices which they have in commercial distribution (including devices produced exclusively for export) A means of keeping FDA advised of the generic categories of devices an establishment is manufacturing or marketingA means of keeping FDA advised of the generic categories of devices an establishment is manufacturing or marketing

18. What is a Medical Device Listing? Required for establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United StatesRequired for establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States Part of General Controls for all medical devicesPart of General Controls for all medical devices Regulations are provided in 21 CFR 807Regulations are provided in 21 CFR 80721 CFR 80721 CFR 807

19. Who Must List Their Medical Device? Almost all establishments who are required to registerAlmost all establishments who are required to register Exceptions are as follows:Exceptions are as follows:  Initial distributors ( importers) located in the U.S.  Refurbishers and domestic distributors

20. How to List Use same procedure and databases as for Establishment RegistrationUse same procedure and databases as for Establishment Registration No additional user fee requiredNo additional user fee required Include the following information:Include the following information:  510(k) clearance # or PMA approval #  product codes for 510(k) exempt devices  proprietary/trade name(s)  the activity performed on the products (e.g., manufacture, design only, repackage, relabel)

21. When to List Must be submitted at the same time as the annual registration (October 1 to December 31)Must be submitted at the same time as the annual registration (October 1 to December 31) Within 30 days of entering the device into commercial distribution in the U.S.Within 30 days of entering the device into commercial distribution in the U.S. Prior to exporting devices to the U.S. (for Foreign Establishments)Prior to exporting devices to the U.S. (for Foreign Establishments) Whenever updates are needed or changes are madeWhenever updates are needed or changes are made

22. Updating of Listing Data Required when all models or variations of a listed device are removed from commercial distribution (i.e., product is discontinued)Required when all models or variations of a listed device are removed from commercial distribution (i.e., product is discontinued) The commercial distribution of a previously-discontinued device is resumedThe commercial distribution of a previously-discontinued device is resumed There is a change in the type of activity performed on a device (i.e., new manufacturing location)There is a change in the type of activity performed on a device (i.e., new manufacturing location)

23. Important Reminders Registration of an establishment or listing of a medical device do not constitute approval of the establishment or its products by FDARegistration of an establishment or listing of a medical device do not constitute approval of the establishment or its products by FDA FDA clearance to market is not granted via registration and listingFDA clearance to market is not granted via registration and listing Any representation (e.g., labeling, promotion, advertising) that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding (21 CFR 807.39)Any representation (e.g., labeling, promotion, advertising) that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding (21 CFR 807.39)

24. Establishment Registration and Device Listing Records Releasable under the Freedom of Information ActReleasable under the Freedom of Information Act Available directly from the internetAvailable directly from the internet Database is updated monthlyDatabase is updated monthly http://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfRL/rl.cfm http://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfRL/rl.cfm

25. Registration & Listing Website www.fda.gov/cdrh/reglistpage.htmlwww.fda.gov/cdrh/reglistpage.htmlwww.fda.gov/cdrh/reglistpage.html –Electronic Registration and Listing –Fees & Payments –Search Registrations and Listings

26. Contact Information E-mail questions regarding FURLS to reglist@cdrh.fda.govE-mail questions regarding FURLS to reglist@cdrh.fda.gov reglist@cdrh.fda.gov E-mail questions regarding user fees to userfees@fda.gov.E-mail questions regarding user fees to userfees@fda.gov.userfees@fda.gov E-mail questions regarding registration and listing policy to dsmica@fda.hhs.govE-mail questions regarding registration and listing policy to dsmica@fda.hhs.gov dsmica@fda.hhs.gov