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HHS/FDA

RIN: 0910-AF71

Publication ID: Spring 2007

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is to determine if any of the regulations in part 820 should be continued without change, or should be amended or rescinded, to minimize adverse economic impacts on small entities.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 is soliciting 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 local 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: 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 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	04/00/2007
End Review	12/00/2007

Regulatory Flexibility Analysis Required: No	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
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