Any establishment, both domestic and foreign, involved in the manufacturing, reprocessing, importation, or development of a medical device intended for commercial sale in the United States must register annually with the US Food and Drug Administration (FDA).
Establishment Registration:
The US FDA requires owners and operators of facilities that are involved in the production and distribution of medical devices intended for use in the United States, whether they are located domestically or outside of the US, to register their facility, annually updating this registration with the agency. This administrative process is known as establishment registration (Title 21 CFR Part 807).
Establishment registration consists of two parts:
- Paying the Annual Registration Fee via the Device Facility User Fee (DFUF) Website
- Completing and Submitting the Establishment Registration via the FDA’s Unified Registration and Listing System (FURLS)
Device Registration
In most cases, registered facilities are also required to submit a list of the devices and the activities performed on those devices at that establishment to the FDA Unified Registration and Listing System (FURLS) using the FDA Device Registration and Listing Module (DRLM). If a device requires a premarket submission before being marketed in the U.S., such as a 510(k), De Novo, PMTA, PDP, or HDE, then the applicant should also provide the FDA premarket submission number in their registration.
In the device registration, it is required to list and provide information about all devices manufactured, processed, distributed, or imported at the facility. Initial importers must additionally list all manufacturers of the devices they are importing.
Who Is Required to Register
*This list is not exhaustive and does not represent all required registrants. Contact us to discuss if your specific establishment is required to register with the FDA.
Domestic Establishments
- Contract Manufacturers (Including Contract Packers)
- Contract Sterilizers
- Initial Importers
- Manufacturer of Accessories or Components That Are Packaged or Labeled for Commercial Distribution for Health-Related Purposes to an End User
- Manufacturer (Including Kit Assemblers)
- Manufacturers of a Custom Device
- Remanufacturers
- Relabelers or Repackers
- Reprocessors
- Specification Developers
Foreign Establishments
- Contract Manufacturers (Including Contract Packers)
- Custom Device Manufacturers
- Foreign Exporter of Devices Located in a Foreign Country
- Foreign Manufacturers (Including Kit Assemblers)
- Manufacturer of Accessories or Components for Distribution for Health-Related Purposes to an End User
- Relabelers Or Repackagers
- Remanufacturers
- Reprocessors of Single Use Devices
- Specification Developers
It is important to note that establishment registration and device registration are separate processes from a 510(k) or pre-market authorization and for class II and class III medical devices (and some Class I devices) these registrations alone do not grant these devices market authorization in the US. Facility and device registration typically is completed after the medical device has been granted market authorization through a separate regulatory pathway.
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