FDA postpones device establishment registrations
This article was originally published in The Gray Sheet
Executive Summary
Annual registration process for all currently registered medical device establishments is postponed until October or November to accommodate anticipated changes. Pending legislation in Congress to reauthorize FDA user fees includes new annual fees for establishment registration and could impact registration requirements, FDA advises (1"The Gray Sheet" June 25, 2007, p. 3). Future registrations and listings will be required to be electronic, which FDA says will make the process "quicker and easier," and help avoid mistakes through built-in error checking. The agency also is simplifying registration requirements to make them easier to understand, and to provide greater flexibility in device descriptions. In addition, FDA will implement the Bioterrorism Act, which will require foreign establishments to provide names of all importers of their devices into the United States. The agency notes that for establishments already registered for this year, the registrations will remain valid until Dec. 31, and registrations for all new establishments will continue uninterrupted...