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.