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HHS/FDA RIN: 0910-AF76 Publication ID: Spring 2008 
Title: Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents(Completion of a Section 610 Review) 
Abstract: FDA has undertaking a review of 21 CFR sections 809.10 and 809.30 under section 610 of the Regulatory Flexibility Act. The purpose of the review was to determine whether the regulations in sections 809.10 and 809.30 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on substantial numbers of small entities. FDA has solicited comments on, the following (1) The continued need for the regulation in part 809; (2) the nature of complaints or comments received concerning the regulation in sections 809.10 and 809.30; (3) the complexity of the regulation in sections 809.10 and 809.30; (4) the extent to which the regulation in sections 809.10 and 809.30 overlaps, duplicates, or conflicts with other Federal, State, or governmental rules: and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the regulation in sections 809.10 and 809.30. The section 610 review has been carried out along with a regulation review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the agency's regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President's priorities and the principles set forth in the Executive order. The agency did not receive any comments during the review process of sections 809.10 and 809.30 under section 610 review. FDA's review of these regulations concluded that they should be continued without change. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a 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
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  04/01/2007    
End Review  11/30/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Madhusoodana Nambiar
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-5837
Fax:301 847-8145
Email: madhusoodana.nambiar@fda.hhs.gov