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HHS/FDA | RIN: 0910-AH65 | Publication ID: Fall 2017 |
Title: ●Radiological Health; Amendments to Records and Report Regulations | |
Abstract:
The rule will update FDA radiological health regulations and withdraw parts of the general provisions, records and reports requirements, and electronic performance standards for radiological devices. Current regulations contain radiation protection recommendations, reporting requirements for manufacturers and assemblers of electronic products, and performance standards for certain electronic products. Some of the current regulations apply to electronic products (i.e., not necessarily having a medical application) but not devices (i.e., having a medical application). The DFR/PR regulation would eliminate radiation protection recommendations, reporting requirements for certain electronic products, and performance standards that have been identified as obsolete and no longer necessary. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 1000.3(s) 21 CFR 1000.50 21 CFR 1000.55 21 CFR 1000.60 21 CFR 1002.1 21 CFR 1002.2 21 CFR 1002.13(c) 21 CFR 1020.30(d)(1) 21 CFR 1040.10(j) 21 CFR 1050 ... (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360 21 U.S.C. 360e to 360j 21 U.S.C. 360hh to 360ss 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381 ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Erica Payne Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring, MD 20993 Phone:301 796-3999 Fax:301 847-8145 Email: erica.payne@fda.hhs.gov |