0910-AF88 200804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Electronic Registration and Listing for Devices FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 510(p) of the Federal Food, Drug, and Cosmetic Act (the act). Section 510(p) was added to the act by section 207 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and later amended by section 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This proposed rule would require domestic and foreign device establishments to submit registration and listing data electronically via the Internet using FDA’s Unified Registration and Listing System. This proposed rule would convert registration and listing to a paperless process. However, for those companies that do not have access to the Web, FDA would offer an avenue by which they can register, list, and update information with a paper submission. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 807 PL 107-188, sec 321 21 USC 360(p) Yes NPRM 12/00/2008 No Businesses None Undetermined No Not Collected Nancy Pirt 0910 Food and Drug Administration FDA 301 796-6248 301 847-8145 nancy.pirt@fda.hhs.gov Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue, Silver Spring MD 20993