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HHS/FDA RIN: 0910-AH65 Publication ID: Fall 2018 
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 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 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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  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   
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  10/00/2018 
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:
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