FDA to Require Medical Device Importers to Participate in Electronic Registration
The Food and Drug Administration is amending its regulations to comply with statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it said in a Federal Register notice. It said the change would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act and update rules to improve the quality of registration and listing information available to FDA.
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FDA said it has developed a system that makes the electronic receipt of device registration and listing information feasible. This final rule updates the regulations to require that registration and listing information be provided to FDA electronically unless FDA grants a request for a waiver.
FDA said it believes this electronic system will ultimately make the process of submitting registration and listing information for devices more efficient for industry and will provide faster access to this information for the FDA and industry, and will allow FDA to more effectively gather information about marketed devices. It said it uses the information to:
- Identify establishments producing marketed medical devices;
- Identify establishments producing a specific device when that device is in short supply or is needed for a national emergency.
- Facilitate the recall of devices marketed by owners or operators of device establishments;
- Identify and catalog marketed devices;
- Administer FDA postmarketing surveillance programs for devices;
- Identify devices marketed in violation of the law;
- Identify and control devices imported or offered for import; Schedule and plan inspections of registered establishments under section 704 of the FD&C Act (21 U.S.C. 374).
Each owner or operator is to establish an account on FDA's online device establishment registration and device listing system, FURLS, which will be used to create and update their device establishment registration and device listing information. Information submitted to FDA prior to Sept. 15, 2007, has already been migrated to the new FURLS electronic database, so there is no need to reenter this information.
Further information: Ann Ferriter, 301-796-5686.