Do you manufacture, distribute, or import medical devices for sale in the US (even if for eventual export)?
If so, you likely need to register your establishment with the FDA. This applies to both domestic and foreign companies involved in the US medical device market. There's an annual registration process outlined in Title 21 CFR Part 807.
What about listing your devices?
Most establishments that register will also need to list the specific medical devices they handle and the activities performed on those devices at their facility.
The included charts break it down further:
These charts categorize the registration and listing requirements based on the specific activities your establishment performs. They'll also clarify which activities require an annual registration fee.
Domestic Establishments
Activity | Register | List | Fee |
Contract Manufacturer (including packagers) | YES | YES | YES |
Contract Sterilizer | YES | YES | YES |
Device under Investigation (IDE) | NO | NO | NO |
Initial Importer | YES | NO | Identify manufacturer |
Maintains Complaint Files | YES | N/A | YES |
Manufacturer (all types) | YES | YES | YES |
Refurbisher/Remarketer (Used Devices) | NO | NO | NO |
Relabeler/Repackager | YES | YES | YES |
Remanufacturer | YES | YES | YES |
Reprocessor (Single-Use Devices) | YES | YES | YES |
Specification Consultant Only | NO | NO | NO |
Specification Developer | YES | YES | YES |
U.S. Manufacturer (Export Only) | YES | YES | YES |
Wholesale Distributor (not manufacturer/importer) | NO | NO | NO |
Foreign Establishments
Activity | Register | List | Fee |
Contract Manufacturer (including packagers) | YES | YES | YES |
Contract Sterilizer | YES | YES | YES |
Custom Device Manufacturer | YES | YES | YES |
Device under Investigation (IDE) | NO | NO | NO |
Foreign Exporter | YES | YES | YES |
Foreign Manufacturer (including Kit Assemblers) | YES | YES | YES |
Maintains Complaint Files (US Distributor) | YES | N/A | YES |
Manufacturer of Accessories/Components (End User) | YES | YES | YES |
Remanufacturer | YES | YES | YES |
Reprocessor (Single-Use Devices) | YES | YES | YES |
Specification Developer | YES | N/A | YES |
Note:
"N/A" applies when listing is not required.
"Identify manufacturer" means providing the FDA with the manufacturer details for imported devices.
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