This post was written by Erin Janssen.
The FDA issued a final rule in August amending current regulations to reflect recent statutory amendments to the device registration and listing provisions of the FD&C Act. The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act to require domestic and foreign device establishments to submit their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments must submit such information. In addition, the final rule facilitates FDA’s collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule also updates certain provisions in the regulations to improve the quality of registration and listing information available to FDA. The final rule is effective October 1, 2012.