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HHS/FDA RIN: 0910-AF76 Publication ID: Fall 2006 
Title: Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents(Section 610 Review) 
Abstract: 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of this review is to determine if 21 CFR 809.10 and 809.30 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities.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 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR 809.10 and 809.30; 3) the complexity of 21 CFR 809.10 and 809.30; 4) the extent to which 21 CFR 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 809.10 and 809.30. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 809.10    21 CFR 809.30   
Legal Authority: 21 USC 351    21 USC 352    21 USC 360j   
Legal Deadline:  None
Action Date FR Cite
Begin Review of Current Regulation  12/00/2006    
End Review of Current Regulation  11/00/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145

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