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HHS/FDA RIN: 0910-AI26 Publication ID: Fall 2019 
Title: Classification of Wound Dressings Containing Antimicrobials, Drugs and/or Other Chemicals 
Abstract:

FDA is proposing to classify the following three categories of unclassified, preamendment wound dressings that contain antimicrobials, drugs, and/or other chemicals under product code FRO:  Solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 21 CFR 878   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360e    21 U.S.C. 360i    21 U.S.C. 360j    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  05/00/2020 
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:
Adaeze Teme
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5574, Center for Devices and Radiological Health,
Silver Spring, MD 20993
Phone:240 402-0768
Email: adaeze.teme@fda.hhs.gov