Top 10 Changes to U.S. FDA Medical Device Registrations and Listings
The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:
- All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
- Combination products (i.e. products comprising a medical device and a biological product or a drug) must be identified as a combination product and the type of combination product.
- All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
- Initial importers must identify the manufacturers of the medical devices they are importing.
- Foreign establishments that are exporting medical devices or offering medical devices for export to the U.S. must identify all known U.S. importers of their devices.
- A device must be listed by the manufacturer, specification developer, single-use medical device reprocessor, remanufacturer, or repacker /relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
- Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”
- 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 Food and Drug Administration Safety and Innovation Action (FDASIA).
- To have your medical device registration, renewal, and listing submitted to FDA by a Regulatory Specialist, simply contact Registrar Corp at +1-757-224-0177. Registrar Corp’s Regulatory Specialist are available to assist you as the new requirements take effect on October 1, 2012. For 24/7 Live Help, visit www.registrarcorp.com/livehelp