0910-AH75 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Fully or Partially Exempt 21 CFR 860 21 U.S.C. 360c 21 U.S.C. 360e No NPRM 03/25/2014 79 FR 16225 Final Action 11/00/2018 No No None No No No Ana Loloei Policy Advisor 0910 Food and Drug Administration FDA 301 796-8774 anahita.loloeimarsal@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5504, Silver Spring MD 20993