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HHS/FDA RIN: 0910-AH75 Publication ID: Fall 2017 
Title: ●Medical Devices; Medical Device Classification 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.  Where feasible, FDA is also amending its regulations to authorize the use of administrative orders in other FDA reclassification proceedings and to update and to clarify its Part 860 regulations.  FDA expects this rulemaking to be in part a deregulatory action under Executive Order 13771 because two FDA forms (FDA 3427 and FDA 3429) would be eliminated and our existing procedures would be streamlined by shifting to the use of administrative orders instead of regulations to propose and to finalize reclassification actions in response to petitions and at FDA initiative.  There is a minimal net burden due to learning and training costs associated with the finalized changes.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/25/2014  79 FR 16225   
Final Action  10/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Marjorie Shulman
Chief, Premarket Notification Staff
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 1536,
Silver Spring, MD 20993
Phone:811 287-1373