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HHS/FDA RIN: 0910-AI26 Publication ID: Fall 2023 
Title: Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes 
Abstract:

FDA is proposing to classify the following three categories of unclassified, preamendments devices containing antimicrobials and/or other chemicals: certain solid wound dressings, wound dressings formulated as gels, creams, and ointments, and liquid wound washes, currently in product codes FRO, GER, MGP, MGQ, and EFQ.

 
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  11/00/2023 
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