The FDA collects fees from companies that produce certain products, such as drugs and medical devices, which are called “User Fees”.
User fees help the FDA fulfill its mission of protecting the public health and also facilitate timely availability of innovative FDA-regulated products without compromising the agency’s commitment to scientific integrity, public health, regulatory standards, patient safety, and transparency.
To support its public health activities, the FDA relies on:
- annual funding that Congress provides for the agency
- user fees paid by industries that make and market FDA-regulated products, and user fees paid by certain other entities.
Medical device user fees were first established in 2002 in the Medical Device User Fee and Modernization Act (MDUFMA), and must be reauthorized by Congress every five years. The medical device user fees were renewed with the Medical Device User Fee Amendments (MDUFA), 2007 (MDUFA II), 2012 (MDUFA III), 2017 (MDUFA IV) and 2022 (MDUFA V).
Here are the requirements for registration and listing based on the type of activity performed. The charts also includes which types of activities require payment of the establishment registration fee.
| Activity | Register |
|---|---|
| Contract Manufacturer (including contract packagers) |
YES |
| Contract Sterilizer | YES |
| Custom Device Manufacturers | YES |
| Device Being Investigated under IDE | NO |
| Foreign Exporter of devices located in a foreign country | YES |
| Foreign Manufacturers (including Kit Assemblers) |
YES |
| Maintains complaint files as required under 21 CFR 820.198 | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user |
YES |
| Manufacturer of components that are distributed only to a finished device manufacturer | NO |
| Relabeler or Repackager | YES |
| Remanufacturer | YES |
| Reprocessor of Single-use Device | YES |
| Specification Developer | YES |
| Activity | List |
|---|---|
| Contract Manufacturer (including contract packagers) |
YES |
| Contract Sterilizer | YES |
| Custom Device Manufacturers | YES |
| Device Being Investigated under IDE | NO |
| Foreign Exporter of devices located in a foreign country | YES |
| Foreign Manufacturers (including Kit Assemblers) |
YES |
| Maintains complaint files as required under 21 CFR 820.198 | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user |
YES |
| Manufacturer of components that are distributed only to a finished device manufacturer | NO |
| Relabeler or Repackager | YES |
| Remanufacturer | YES |
| Reprocessor of Single-use Device | YES |
| Specification Developer | YES |
| Activity | Pay Fee |
|---|---|
| Contract Manufacturer (including contract packagers) |
YES |
| Contract Sterilizer | YES |
| Custom Device Manufacturers | YES |
| Device Being Investigated under IDE | NO |
| Foreign Exporter of devices located in a foreign country |
YES |
| Foreign Manufacturers (including Kit Assemblers) |
YES |
| Maintains complaint files as required under 21 CFR 820.198 |
YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user |
YES |
| Manufacturer of components that are distributed only to a finished device manufacturer |
NO |
| Relabeler or Repackager | YES |
| Remanufacturer | YES |
| Reprocessor of Single-use Device | YES |
| Specification Developer | YES |
Establishments that are involved in the production and distribution of medical devices intended for the United States market, including those that are imported for export only, are required to register annually with the FDA.
Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.
Unlike Service Fees, User Fees are paid to the United States Department of the Treasury.
However, both fees are required, when the assistance of a U.S. Agent, such as ITB HOLDINGS LLC, is requested.
