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HHS/FDA RIN: 0910-AH67 Publication ID: Fall 2018 
Title: Amendments and Repeal to Medical Device Software Regulations 
Abstract:

The 21st Century Cures Act amended the definition of device under the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of device and therefore FDA’s jurisdiction.  FDA will revise its regulations to be consistent with this statutory change.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
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 862.2100    21 CFR 880.6310    21 CFR 892.2010   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360j    21 U.S.C. 360l    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
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