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HHS/FDA RIN: 0910-AH53 Publication ID: Spring 2020 
Title: Medical Device De Novo Classification Process 

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. By clarifying and making more efficient the De Novo request requirements, we expect the rule would reduce the time and costs associated with reviewing De Novo requests and generate net benefits in the form of cost savings.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
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
Action Date FR Cite
NPRM  12/07/2018  83 FR 63127   
NPRM Comment Period End  03/07/2019 
Final Rule  09/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
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