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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.

 
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
Timetable:
Action Date FR Cite
Direct Final Rule  09/00/2018 
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 5522,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov