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HHS/FDA RIN: 0910-AF71 Publication ID: Fall 2007 
Title: Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations(Completion of a Section 610 Review) 
Abstract: FDA has undertaking a review of part 820 under section 610 of the Regulatory Flexibility Act. The agency did not receive any comments during the review process of part 820 under section 610 review, therefore the regulation will continue without change. The purpose of the review was to determine whether the regulations in part 820 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on substantial number of small entities. FDA has solicited comments on, the following (1) the continued need for the regulation in part 820; (2) the nature of complaints or comments received concerning the regulation in part 820; (3) the complexity of the regulation in part 820; (4) the extent to which the regulation in part 820 overlap, duplicate, or conflict 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 part 820. 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 combined effect of the two reviews will be to determine if it is possible to redesign current good manufacturing practices in ways that will maintain or increase the effectiveness of preventive and sanitary controls, and, at the same time, reduce compliance and other costs associated with the regulations. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
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 808    21 CFR 812    21 CFR 820   
Legal Authority: 5 USC 610   
Legal Deadline:  None
Action Date FR Cite
Begin Review of Current Regulation  01/05/2006    
End Review  07/31/2007    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
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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