View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AH53 Publication ID: Spring 2017 
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: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
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  11/00/2017 
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
Email: laurie.sternberg@fda.hhs.gov