FDA: Annual Device Establishment Registration for 2008 Postponed

The FDA announced it is postponing the annual registration of medical device establishments for 2008.

The agency said this is a temporary action and it expects to resume annual registrations in October or November 2007. Establishments that are already registered for 2007 are valid until Dec. 31.

The FDA said it is postponing registration because changes that may take place in the next several months could “significantly change” the way manufacturers register their establishments and list their devices. These changes could include electronic registration and listing, simpler registration and listing requirements and provisions under the Bioterrorism Act and the Medical Device User Fee and Modernization Act.

In conjunction with its planned transition to electronic registration and listing, the FDA said it is working to complete a revision of its regulations on medical device establishment registration and medical device listing.

Manufacturers with questions should call (240) 276-0111 or send an email to device.reg@fda.hhs.gov.