FDA Guidance - Device Registration and Listing Requirements

The Food and Drug Administration (FDA) announced the availability of the guidance entitled "Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.''

The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Return Home: http://drughealth.blogspot.com/
GMP Posters
The Health, Drug, Prescription, and GMP Supersite Gift Store
Return to Mobile Home: http://drughealth.mofuse.mobi/

Related articles by Zemanta

• F.D.A. Admits Error on Knee Device (nytimes.com)
• FDA awards $2M in grants for kids' medical devices (seattletimes.nwsource.com)
• FDA's Device Chief Leaving His Job - These are Big Shoes To Fill with Clinical and IT Knowledge Required (ducknetweb.blogspot.com)