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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determine whether the regulations in part 820 should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on substantial number of small entities.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 |
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Timetable:
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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: 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 |