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HHS/FDA RIN: 0910-AH75 Publication ID: Fall 2018 
Title: Medical Devices; Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures  

The Final Rule implements Section 608 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requiring FDA to use administrative orders to announce or to change the classification of devices, instead of taking action by regulation.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 860   
Legal Authority: 21 U.S.C. 360c    21 U.S.C. 360e   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/25/2014  79 FR 16225   
Final Action  11/00/2018 
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:
Anahita Marsal-Loloei
Policy Advisor
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5504,
Silver Spring, MD 20993
Phone:301 796-8774