0910-AF71 200510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 820. The purpose of this review is to determine if any of the regulations in part 820 should be continued without change, or should be amended or rescinded, to minimize adverse economic impacts on small entities. FDA will consider and solicit comments on the following; 1) The continued need for a regulation in part 820; 2) the nature of complaints or comments received concerning a regulation in part 820; 3) the complexity of a regulation in part 820; 4) the extent to which a regulation in part 820 overlaps, duplicates, or conflicts with other Federal, State, or government rules; and 5) the degree to which technology economic conditions or other factors have changed in the area affected by a regulation in part 820. Routine and Frequent First Time Published in The Unified Agenda Prerule Stage No No Section 610 Review 21 CFR 808 21 CFR 812 21 CFR 820 5 USC 610 No Begin Review of Current Regulation 11/00/2005 No Undetermined NA 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