As of Oct. 1, 2012, medical device establishments will be required to follow these new registration/listing requirements and responsibilities:
- All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
- Drug/device combination products must be identified as a combination product, and the type of combination product (e.g., convenience kit, prefilled drug delivery device, etc.) must be selected from the list displayed in the FDA Unified Registration and Listing System (FURLS).
- All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
- Initial importers must identify the manufacturers of the devices they are importing.
- Foreign establishments exporting devices to the U.S. must identify all known U.S. importers of their devices.
- Before a foreign exporter, contract manufacturer or contract sterilizer can list a device, it must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer or repacker/relabeler.
- Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment” as required by 21 CFR 820.198.
- Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
- All establishments that are required to register must now pay the annual registration user fee as required by the Food and Drug Administration Safety and Innovation Act (FDASIA).
On Sept. 12, 2012, FDA released a document entitled “Frequently Asked Questions about the New Device Registration and Listing Requirements.” The purpose of the FAQs is to assist medical device establishments in understanding and complying with the new requirements and responsibilities for registration and listing.
For advice on whether your company must comply with these new requirements, and how to do so, please contact us.