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HHS/FDA RIN: 0910-AH67 Publication ID: Fall 2017 
Title: ●Medical Devices; Amendments to Medical 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 351    21 U.S.C. 360.21    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Direct Final Rule  10/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Erica Blake-Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5522, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov