The FDA has compiled a list of FAQs provided to assist medical device establishments with understanding the new requirements and responsibilities for registration and listing that become effective today, October 1, 2012.
The information includes a list of changes to medical device listing and registration, updating existing information, proprietary (brand) names, combination products, the new medical device excise tax, and information for foreign establishments, exporters, importers, and contract manufacturers and sterilizers.
Some of the changes include:
- 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.
- Combination products – products comprising a device and a biological product or a drug – must be identified as a combination product and the type of combination product (for example, 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.
