0910-AF76 200710 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: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents FDA is initiating a review under section 610 of the Regulatory Flexibility Act for two regulations in part 809. The purpose of this review is to determine if 21 CFR part 809.10 and 809.30 should be continued without change, or should be amended or rescinded to minimize adverse economic impact on small entities. FDA is soliciting and will consider comments on the following: 1) The continued need for 21 CFR part 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR part 809.10 and 809.30; 3) the complexity of 21 CFR part 809.10 and 809.30; 4) the extent to which 21 CFR part 809.10 and 809.30 overlap, duplicate, or conflict with other Federal, State, or local government rules; and 5) the degree to which technology, economic conditions, or other factors have changed in the area affected by 21 CFR part 809.10 and 809.30. Other Significant Previously Published in The Unified Agenda Prerule Stage No No Section 610 Review 21 CFR 809.10 21 CFR 809.30 21 USC 351 21 USC 352 21 USC 360j No Begin Review of Current Regulation 04/01/2007 End Review 11/00/2007 No No None Yes 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