FAQ: Medical Device Facility Registrations
WHAT IS THE MEDICAL DEVICE FACILITY REGISTRATION REQUIREMENT?
The FDA requires facilities that are manufacturing, preparing, propagating, compounding, or processing medical devices to annually register the establishment and list the devices. Registration, which includes consent to an FDA inspection, is a threshold requirement for exporting device from an overseas market to the US and importing and selling devices in the U.S.
WHEN MUST FACILITIES REGISTER OR RENEW?
Domestic establishments must register 30 days before putting a device into commercial distribution. Foreign establishments must register before exporting to the U.S. for the first time. Initial importers must register prior to importing to the U.S. for the first time, and only need to register, no need to list. Initial importers must identify the manufacturer of each device imported. Establishments must certify their information is complete and accurate every year between October 1 and December 31.
WHO MUST REGISTER?
- domestic and foreign manufacturers / remanufacturers, kit assemblers
- domestic and foreign repackers / relabelers
- domestic and foreign contract manufacturers / sterilizers
- domestic and foreign reprocessors of single use devices
- domestic and foreign complaint handlers
- domestic initial importers (initial distributors)
- foreign exporters and private label distributors
WHO IS EXEMPT?
- a manufacturer of raw materials or components used in the manufacture or assembly of a device
- a manufacturer of devices used solely for veterinary purposes - regulated by FDA's CVM
- licensed practitioners who manufacture or otherwise alter devices solely for use in their practice (i.e. physicians, dentists, optometrists)
- retail establishments that provide devices directly to end users (i.e. pharmacies, surgical supply outlets, etc.)
- persons who manufacturer, prepare, propagate, compound or process devices solely for use in research, teaching or analysis and do not introduce such devices into commercial distribution.
You may seek a legal opinion demonstrating your status as an exempt facility from FDA registration.
WHAT IS INVOLVED IN REGISTERING?
Information on the initial registration includes:
- pay the annual registration fee
- register the establishment in the FDA FURLS system
- provide information about the establishment Owner Operator and Official Correspondent
- create at least one listing at the time of initial registration
- identify all proprietary names under which the product is marketed in the U.S.
- foreign establishments must also identify a U.S. Agent
There is an abbreviated process for registration renewals.
WHAT IS A US AGENT?
Foreign establishments must designate a U.S. agent for communication with the FDA. This must be a person, partnership, corporation or association who has a place of business or residence and is physically present in the United States. The U.S. Agent serves as a communication link between the FDA and the foreign establishment.
WHAT IF A FACILITY FAILS TO REGISTER OR RENEW?
Devices are considered misbranded if manufactured, prepared, propagated, compounded or processed in a non-registered establishment and not included on a list. Products that are not registered cannot enter, although it may be possible to cure the violation at time of entry.