The Food and Drug Administration is now accepting registration renewals for medical device facilities.
According to the FDA, ALL establishments that are involved in the production and/or distribution of medical devices sold in the U.S., including those that are imported for export only, are required to register annually with the FDA. This includes:
- Foreign and domestic contract manufacturers
- Specification developers
- Relabelers and repackers
- Initial importers and foreign exporters
While registration renewals are being accepted through December 31, we encourage you to renew early to avoid unnecessary disruption. Failure to submit, renew, update, or cancel a registration may result in civil or criminal penalties as well as import restrictions.
Requirements
In most cases, establishments that are required to register with FDA are also required to list all devices that are made in their facilities as well as the activities that are performed on those devices. Additionally, if a device requires a premarket submission before being marketed in the U.S., then the owner or operator should also provide the FDA premarket submission number.
When registering and listing your device, there are some key documents you must have readily available to make this process as quick and easy as possible. These include:
- An updated list of products manufactured or offered for wholesale distribution by the registrant
- Product descriptions
- Labeling information
- Regulatory certificates
- Specific test information, if applicable
Useful Links
The FDA provides helpful guidance on the medical device registration process, including a chart detailing the requirements for registration, listing, and fee based on the activity of the establishment. Be sure to pay close attention to the requirements, as there are numerous examples in which a specific product requires all, some, or none of these steps.
The FDA also offers the following tutorials:
- Device Registration and Listing
- Paying the Annual Registration User Fee via the Device Facility User Fee Website
- FURLS Device Registration and Listing Module for Initial Registration
- FURLS Device Registration and Listing Module for Annual Registration
For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at:
Phone: 301-796-7400
Email: reglist@cdrh.fda.gov
