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HHS/FDA RIN: 0910-AI26 Publication ID: Spring 2022 
Title: Classification of Wound Dressings Containing Antimicrobials and/or Other Chemicals 
Abstract:

FDA is proposing to classify the following three categories of unclassified, preamendments wound dressings that contain antimicrobials, and/or other chemicals currently grouped 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 
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  12/00/2022 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Gugandeep Kaur
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66 ,
Silver Spring, MD 20993
Phone:240 432-8301
Email: gugandeep.kaur@fda.hhs.gov