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HHS/FDA RIN: 0910-AH53 Publication ID: Spring 2018 
Title: Medical Device De Novo Classification Process 
Abstract:

De novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market their devices.  The proposed rule would establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers.

 
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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 860   
Legal Authority: 21 U.S.C. 513    21 U.S.C. 701   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Jean M. Olson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5506,
Silver Spring, MD 20993
Phone:301 796-6579
Email: jean.olson@fda.hhs.gov