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| HHS/FDA | RIN: 0910-AF76 | Publication ID: Fall 2007 |
| 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review is to determine if 21 CFR part 809.10 and 809.30 should be continued without change, or should be amended or rescinded to minimize adverse economic impact on small entities.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 part 809.10 and 809.30; 2) the nature of complaints or comments received concerning 21 CFR part 809.10 and 809.30; 3) the complexity of 21 CFR part 809.10 and 809.30; 4) the extent to which 21 CFR part 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 part 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 | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone:240 276-2347 Fax:240 276-2352 Email: myrna.hanna@fda.hhs.gov |
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