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HHS/FDA RIN: 0910-AF71 Publication ID: Fall 2005 
Title: ●Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality Systems Regulations(Section 610 Review) 
Abstract: 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is to determine if any of the regulations in part 820 should be continued without change, or should be amended or rescinded, to minimize adverse economic impacts on small entities.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. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: First time 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 808; 21 CFR 812; 21 CFR 820 
Legal Authority: 5 USC 610 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  11/00/2005   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Federalism: Undetermined 
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
Email: nancy.pirt@fda.hhs.gov

 
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