Medical Devices
Device Registration and Listing
Frequently Asked Questions about the New Device Registration and Listing Requirements
Please contact reglist@cdrh.fda.gov for further information.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.
Congress has authorized FDA to collect an annual establishment registration fee for device establishment registrations. A detailed list of all those establishment types that have to pay the registration fee can be found at "Who Must Register, List and Pay the Fee". There are no reductions in annual establishment registration fees for small businesses or any other group
The schedule of registration fees for fiscal years as follows:
| Year | FY 2012 | FY 2013 |
|---|---|---|
| Fee | $2,029 | $2,575 |
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Note: If you encounter an issue or wish to contact us regarding the Electronic Registration and Listing System (FURLS), please send an email to reglist@cdrh.fda.gov.
Public reporting burden for this collection of information on form FDA 3673 is estimated to be 0.50 hours per response for the purpose of firms annually registering their establishment and 0.25 hours per response for the purpose of firms annually listing their devices. These estimates are based on FDA's experience, data from the device registration and listing database, and our estimates of the time needed to complete other previously required forms.
Send comments regarding this burden estimate or another aspect of this collection of information, including suggestions for reducing this burden to:
Office of Information Management,
Food and Drug Administration,
1350 Piccard Dr.,
PI50-400B,
Rockville, MD 20850
