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MEDICAL
USER FEES
WHO PAYS USER FEES FOR MEDICAL DEVICE ESTABLISHMENT REGISTRATION

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.