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| HHS/FDA | RIN: 0910-AF76 | Publication ID: Fall 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 two regulations in part 809. The purpose of this review is to determine if 21 CFR 809.10 and 809.30 should be continued without change, or should be amended or rescinded, to minimize adverse economic impact on small entities. FDA is soliciting and will consider comments on the following: 1) The continued need for 21 CFR 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR 809.10 and 809.30; 3) the complexity of 21 CFR 809.10 and 809.30; 4) the extent to which 21 CFR 809.10 and 809.30 overlap, duplicate, or conflict 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 21 CFR 809.10 and 809.30. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| 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 809.10; 21 CFR 809.30 | |
| Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360j | |
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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 | |
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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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