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HHS/FDA RIN: 0910-AH53 Publication ID: Spring 2019 
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 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: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 860   
Legal Authority: 21 U.S.C. 321(h)    21 U.S.C. 360c, 360i-360j    21 U.S.C. 371    21 U.S.C. 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/07/2018  83 FR 63127   
NPRM Comment Period End  03/07/2019 
Final Rule  06/00/2020 
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:
Laurie Sternberg
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517,
Silver Spring, MD 20993
Phone:240 402-0425
Email: laurie.sternberg@fda.hhs.gov