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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-510-2240
MEDICAL

USER FEES

WHO PAYS USER FEES
FOR MEDICAL DEVICE ESTABLISHMENT REGISTRATION

The FDA collects fees from companies that produce certain products, such as drugs and medical devices, which are called “User Fees”.

USER FEES EXPLAINED

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.

Foreign Establishments
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
Foreign Establishments
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
Foreign Establishments
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.

Questions?

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