Establishment Registration Establishment Registration and Device Listingand Device Listing

Rod Perez, M.S.E.Rod Perez, M.S.E.

Consumer Safety OfficerConsumer Safety Officer

Division of Small Manufacturers, Division of Small Manufacturers, International and Consumer International and Consumer

AssistanceAssistance

Western Canada 2009Western Canada 2009

TopicsTopics

• Establishment RegistrationEstablishment Registration

• Device ListingDevice Listing

What is Establishment What is Establishment Registration?Registration?

• Process which provides the FDA with the Process which provides the FDA with the location of medical device manufacturing location of medical device manufacturing facilities and importersfacilities and importers

• Required for establishments involved in the Required for establishments involved in the production and distribution of medical devices production and distribution of medical devices intended for marketing or leasing (commercial intended for marketing or leasing (commercial distribution) in the United Statesdistribution) 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 807

DefinitionsDefinitions

• ESTABLISHMENTESTABLISHMENTAny place of business under one management at one Any place of business under one management at one physical location at which a device is manufactured, physical location at which a device is manufactured, assembled or otherwise processed for commercial assembled or otherwise processed for commercial distributiondistribution

• OWNER/OPERATOR OWNER/OPERATOR The corporation, subsidiary, affiliated company, The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the partnership, or proprietor directly responsible for the activities of the registering establishment. The activities of the registering establishment. The owner/operator is responsible for registering the owner/operator is responsible for registering the establishmentestablishment

BackgroundBackground

• Effective October 1, 2007, all registration Effective October 1, 2007, all registration and listing information must be submitted and listing information must be submitted electronicallyelectronically

• All annual registrations must take place All annual registrations must take place between October 1 and December 31 of between October 1 and December 31 of each yeareach year

• There is a user fee for establishment There is a user fee for establishment registration (initial and annual) for most registration (initial and annual) for most establishment typesestablishment types

WaiversWaivers

• Waivers to the electronic submission Waivers to the electronic submission requirement can be requested in requirement can be requested in writing and granted “because writing and granted “because electronic R&L is not reasonable…”electronic R&L is not reasonable…”

• FDA does not anticipate there will be FDA does not anticipate there will be many instances in which electronic many instances in which electronic submission of R&L is not reasonablesubmission of R&L is not reasonable

• Still responsible for any feeStill responsible for any fee

User FeesUser Fees

• $2,008 USD in FY 10 (October 2009-$2,008 USD in FY 10 (October 2009-September 2010)September 2010)

• No reduction for small businesses or other No reduction for small businesses or other groupsgroups

• Paid by:Paid by:– Device manufacturersDevice manufacturers– Contract sterilizers and manufacturers Contract sterilizers and manufacturers

• if they put into commercial distributionif they put into commercial distribution– Single use device reprocessorsSingle use device reprocessors– Specification developersSpecification developers

If You are Required to Pay the If You are Required to Pay the User Fee:User Fee:

• First visit the Device Facility User Fee website to First visit the Device Facility User Fee website to create a medical device facility user fee account create a medical device facility user fee account and pay the fee:and pay the fee:

https://fdasfinapp8.fda.gov/OA_HTML/furls.jsphttps://fdasfinapp8.fda.gov/OA_HTML/furls.jsp

• Once you make payment and receive Once you make payment and receive confirmation numbers for your payment confirmation numbers for your payment (PIN/PCN), you can proceed to the (PIN/PCN), you can proceed to the FURLS FURLS websitewebsite to complete your registration and listing to complete your registration and listing requirements:requirements:

https://www.access.fda.gov/oaahttps://www.access.fda.gov/oaa

How to Pay User FeesHow to Pay User Fees

• Electronic payment by credit card and Electronic payment by credit card and Automated Clearing House (ACH) Automated Clearing House (ACH) electronic checkelectronic check

• Payment by mail with check drawn on a Payment by mail with check drawn on a U.S. Bank (to lock box)U.S. Bank (to lock box)

• Wire transfer in U.S. funds for foreign Wire transfer in U.S. funds for foreign establishmentsestablishments

• Reminder: Can take up to 2 weeks for Reminder: Can take up to 2 weeks for CDRH to be notified of payment by OFMCDRH to be notified of payment by OFM

Who Must Register?Who Must Register?

• Manufacturers (foreign and domestic)Manufacturers (foreign and domestic)

• Contract manufacturers and sterilizers (If Contract manufacturers and sterilizers (If they put into commercial distribution)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

Who Must Register?Who Must Register?

• RemanufacturersRemanufacturers• U.S. manufacturers of export-only U.S. manufacturers of export-only

devicesdevices• Manufacturers of components or Manufacturers of components or

accessories of ready-to-be-used accessories of ready-to-be-used devicesdevices

• Foreign dental and optical Foreign dental and optical laboratorieslaboratories

Who Does Not Have to Who Does Not Have to Register?Register?

• Wholesale distributors of devices who Wholesale distributors of devices who do not manufacturer, repackage, do not manufacturer, repackage, process or relabel a deviceprocess or relabel a device

• Any person importing a device that is Any person importing a device that is for their personal use and not for for their personal use and not for commercial distributioncommercial distribution

• Refurbishers and domestic distributorsRefurbishers and domestic distributors

When to Submit Registration When to Submit Registration Information?Information?

• Within 30 days after beginning Within 30 days after beginning operation (initial registration)operation (initial registration)

• Within 30 days after a changeWithin 30 days after a change

• Review and submit annually between Review and submit annually between October 1 and December 31 of each October 1 and December 31 of each yearyear

Requirements for Foreign Requirements for Foreign EstablishmentsEstablishments

• Same annual requirementsSame annual requirements

• Must notify FDA of initial registration Must notify FDA of initial registration prior to exporting to the U.S.prior to exporting to the U.S.

• Must submit U.S. Agent informationMust submit U.S. Agent information

• Identify known initial distributor (by Identify known initial distributor (by their registration number) for each their registration number) for each listinglisting

U.S. Agent RequirementsU.S. Agent Requirements

• All foreign establishments must notify FDA All foreign establishments must notify FDA of the name, business name, address, of the name, business name, address, phone number, and e-mail address of their phone number, and e-mail address of their U.S. AgentU.S. Agent

• Only one U.S. Agent per establishmentOnly one U.S. Agent per establishment

• The U.S. Agent must either reside in the The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. or maintain a place of business in the U.S.U.S.

Responsibilities Responsibilities of the U.S. Agentof the U.S. Agent

• Assisting FDA in communications with the Assisting FDA in communications with the foreign establishmentforeign establishment

• Responding to questions concerning the Responding to questions concerning the foreign establishment's products being foreign establishment's products being imported into the U.S. imported into the U.S.

• Assisting FDA in scheduling inspections of Assisting FDA in scheduling inspections of the foreign establishment the foreign establishment

• May act as Official CorrespondentMay act as Official Correspondent

What is a Medical Device What is a Medical Device Listing?Listing?

• The process which requires most medical device The process which requires most medical device establishments to register with FDA to also establishments to register with FDA to also identify those devices which they have in identify those devices which they have in commercial distribution (including devices commercial distribution (including devices produced exclusively for export) produced exclusively for export)

• A means of keeping FDA advised of the generic A means of keeping FDA advised of the generic categories of devices an establishment is categories of devices an establishment is manufacturing or marketingmanufacturing or marketing

What is a Medical Device What is a Medical Device Listing?Listing?

• Required for establishments involved in Required for establishments involved in the production and distribution of medical the production and distribution of medical devices intended for marketing or leasing devices intended for marketing or leasing (commercial distribution) in the United (commercial distribution) in the United StatesStates

• Part of General Controls for all medical Part of General Controls for all medical devicesdevices

• Regulations are provided in 21 CFR 807Regulations are provided in 21 CFR 807

Who Must List Their Medical Who Must List Their Medical Device?Device?

• Almost all establishments who are Almost all establishments who are required to registerrequired to register

• Exceptions are as follows:Exceptions are as follows: Initial distributors ( importers) Initial distributors ( importers)

located in the U.S.located in the U.S. Refurbishers and domestic Refurbishers and domestic

distributorsdistributors

How to ListHow to List

• Use same procedure and databases as for Use same procedure and databases as for Establishment RegistrationEstablishment Registration

• No additional user fee requiredNo additional user fee required• Include the following information:Include the following information:

510(k) clearance # or PMA approval #510(k) clearance # or PMA approval # product codes for 510(k) exempt devicesproduct codes for 510(k) exempt devices proprietary/trade name(s) proprietary/trade name(s) the activity performed on the products (e.g., the activity performed on the products (e.g.,

manufacture, design only, repackage, relabel)manufacture, design only, repackage, relabel)

When to ListWhen to List

• Must be submitted at the same time as the Must be submitted at the same time as the annual registration (October 1 to December annual registration (October 1 to December 31)31)

• Within 30 days of entering the device into Within 30 days of entering the device into commercial distribution in the U.S.commercial distribution in the U.S.

• Prior to exporting devices to the U.S. (for Prior to exporting devices to the U.S. (for Foreign Establishments)Foreign Establishments)

• Whenever updates are needed or changes Whenever updates are needed or changes are madeare made

Updating of Listing DataUpdating of Listing Data

• Required when all models or variations of a Required when all models or variations of a listed device are removed from commercial listed device are removed from commercial distribution (i.e., product is discontinued)distribution (i.e., product is discontinued)

• The commercial distribution of a previously-The commercial distribution of a previously-discontinued device is resumeddiscontinued device is resumed

• There is a change in the type of activity There is a change in the type of activity performed on a device (i.e., new performed on a device (i.e., new manufacturing location)manufacturing location)

Important RemindersImportant Reminders

• Registration of an establishment or listing of a Registration of an establishment or listing of a medical device do not constitute approval of the medical device do not constitute approval of the establishment or its products by FDA establishment or its products by FDA

• FDA clearance to market is not granted via FDA clearance to market is not granted via registration and listingregistration and listing

• Any representation (e.g., labeling, promotion, Any representation (e.g., labeling, promotion, advertising) that creates an impression of official advertising) that creates an impression of official approval because of registration or possession approval because of registration or possession of a registration number is misleading and of a registration number is misleading and constitutes misbranding (21 CFR 807.39)constitutes misbranding (21 CFR 807.39)

Establishment Registration Establishment Registration and Device Listing Recordsand Device Listing Records

• Releasable under the Freedom of Releasable under the Freedom of Information ActInformation Act

• Available directly from the internet Available directly from the internet

• Database is updated monthlyDatabase is updated monthly

http://www.accessdata.fda.gov/scripts/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfmcdrh/cfdocs/cfRL/rl.cfm

Registration & ListingRegistration & ListingWebsiteWebsite

• www.fda.gov/cdrh/reglistpage.htmlwww.fda.gov/cdrh/reglistpage.html

–Electronic Registration and ListingElectronic Registration and Listing

–Fees & PaymentsFees & Payments

–Search Registrations and ListingsSearch Registrations and Listings

Contact InformationContact Information

• E-mail questions regarding FURLS to E-mail questions regarding FURLS to reglist@cdrh.fda.govreglist@cdrh.fda.gov

• E-mail questions regarding user fees E-mail questions regarding user fees to userfees@fda.gov. to userfees@fda.gov.

• E-mail questions regarding E-mail questions regarding registration and listing policy to registration and listing policy to dsmica@fda.hhs.govdsmica@fda.hhs.gov