FDA Issues Proposed Rule on Implementation of Device Registration and Listing Requirements
On March 26, 2010, FDA issued a proposed rule to implement its statutory mandate under the Food and Drug Administration Amendments Act of 2007 (FDAAA), as well as other legislation, regarding device registration and listing requirements. The amended regulations would require domestic and foreign device establishments to submit all registration and device listing information electronically, not by paper, to FDA. The regulations also expand the information required to be submitted by foreign establishments, as required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
