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HHS/FDA | RIN: 0910-AF76 | Publication ID: Spring 2006 |
Title: ●Medical Devices: Classification/Reclassification; Restricted Devices; Analyte Specific Reagents(Section 610 Review) | |
Abstract: FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulations in part 809. The purpose of this review is to determine if any of the regulations in part 809 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities. FDA will consider and solicit comments on the following: 1) The continued need for a regulation in part 809; 2) the nature of complaints or comments received concerning a regulation in part 809; 3) the complexity of a regulation in part 809; 4) the extent to which a regulation in part 809 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 809. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
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 809.10 21 CFR 809.30 | |
Legal Authority: 21 USC 351 21 USC 352 21 USC 360j |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
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 |