US FDA Establishment Registration & Device Listing

 21 CFR Part 807

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.

These establishments also necessity to list their devices including premarket submission number (510(k), De Novo, PMA, PDP, HDE).

Registration and listing provide FDA with the location of medical device manufacturing facilities and the list of devices manufactured.

Who Is Required To Register and List

Establishment Type: Domestic /Foreign	Activity	Register	List
Domestic  and Foreign	Manufacturer / Remanufacturer / Kit Assemblers	Yes	Yes
Domestic  and Foreign	Specification Developer	Yes	Yes
Domestic  and Foreign	Contract Manufacturer / Sterilizer	Yes	Yes
Domestic  and Foreign	Repackagers / Relabelers	Yes	Yes
Domestic  and Foreign	Reprocessors of Single Use Devices	Yes	Yes
Domestic  and Foreign	Complaint Handlers	Yes	Yes
Domestic	Initial Importers	Yes	No
Foreign	Foreign Exporter of devices located in a foreign country	Yes	Yes

 Exceptions for Registration & Listing

·       Device being investigated under IDE

·       Domestic Distributor that does not import devices

·       Refurbishers or remarketers of used devices already in commercial distribution in the United States.

·       Wholesale distributor that is not a manufacturer or importer

·       Manufacturer of components, that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer

·       Manufacturers whose devices are used solely in research, teaching, or analysis and not introduced into commercial distribution.

 

When to Register & List

Initial registration timelines are given below

Establishment Type Domestic /Foreign	Timelines
Domestic	Within 30 days of putting a device into commercial distribution
Foreign	Prior to exporting to the United States for the first time
Initial Importers	Prior to importing to the United States for the first time –only register; do no list –must identify the manufacturer of each device imported

 

All manufacturers shall register annually between October 1 through December 31 of each year.if there is any changes then reflect the same in registration and lisiting.

 Register the establishments electronically using FDA Unified Registration and Listing Systems (FURLS). FDA may grant the exception for electronic registration

Foreign establishments need United States agent for registration and listing.

Establishment registration requires establishment type, Owner Operator and Official Correspondent (name, address, phone, email, etc.)

Device listing require product code for the device ,type of activities performed by establishments and proprietary or brand names  and premarket submission number (510(k), De Novo, PMA, PDP, HDE).

 References:

Registration and Listing: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/default.htm

•Who Must Register, List and Pay Fee http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm