Establishment Registration
What is establishment registration?
Establishment registration is an annual process in which those who own or operate establishments involved in producing and distributing medical devices intended to be used in the U.S. must register with the Food and Drug Administration (FDA). There is a fee associated with this registration, and there are no waivers or reductions of this fee for small businesses, establishments, or groups.
Examples of who must register with the FDA include:
- Manufacturers (including kit assemblers)
- Contract sterilizers
- Refurbishers or remarketers
- Relabelers
- Specification developers
When registering with the FDA, these establishments are often required to list the devices made at the establishment and the activities performed on the devices.
How does establishment registration improve healthcare?
Registering with the FDA and providing them with the location of medical establishments and the devices produced at these locations allows the nation to respond quickly to public health emergencies. For example, if a device is malfunctioning, the FDA can quickly trace it through its line of production to remedy the situation and prevent more errors from occurring.