Device Listing Requirements
What is device listing?
Device listing is the requirement for manufacturers (and certain importers) to inform FDA of the devices they are commercially distributing in the USA. It is separate from establishment registration — registration identifies the facility; listing identifies the products.
Who must list?
- Domestic manufacturers listing devices in commercial distribution
- Foreign manufacturers listing devices exported to and commercially distributed in the USA
- Repackagers and relabellers (for devices they repackage/relabel)
- Initial importers (for each device they import for commercial distribution)
What must be listed?
For each device, the listing must include:
- Device name (proprietary and common/generic)
- Product code (from FDA classification database)
- 510(k)/PMA/De Novo number (if applicable)
- Listed device category (Class I/II/III)
- Intended use
- Physical description
When to update listings
- Initial listing — at time of establishment registration or when a new device enters commercial distribution
- Updates — within 30 days of any change in commercial distribution status (adding new devices, ceasing distribution, changes to device information)
- Annual confirmation — manufacturers must confirm or update their listings annually as part of the annual registration renewal