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HHS/FDA RIN: 0910-AH65 Publication ID: Fall 2020 
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reporting requirements for certain electronic products, and performance standards that have been identified as outdated or duplicative of other means to better protect public health.

 
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 
EO 13771 Designation: Deregulatory 
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(c)    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
Timetable:
Action Date FR Cite
NPRM  04/01/2019  84 FR 12147   
NPRM Comment Period End  07/01/2019 
Final Rule  11/00/2020 
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:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 66, Room 5502, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:301 796-9603
Email: karen.fikes@fda.hhs.gov