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HHS/FDA | RIN: 0910-AH65 | Publication ID: Spring 2021 |
Title: Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products | |
Abstract:
The rule will clarify and update FDA radiological health regulations by repealing and amending parts of the general provisions, records and reports requirements, and electronic performance standards for radiation emitting electronic products and medical 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 revisions will amend and repeal certain radiation protection recommendations, reporting requirements for certain electronic products, and performance standards that have been identified as outdated or duplicative of other means to better protect public health. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1000.3 21 CFR 1000.50 21 CFR 1000.55 21 CFR 1000.60 21 CFR 1002.1 21 CFR 1002.2 21 CFR 1002.13 21 CFR 1002.20 21 CFR 1010.4 21 CFR 1020.30 21 CFR 1040.10 21 CFR 1050 | |
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: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Rachel Hunt Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 66, Center for Devices and Radiological Health, Silver Spring, MD 20993 Phone:240 402-5244 Email: rachel.hunt@fda.hhs.gov |