Regulatory Counsel

0910-AI26 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes

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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 878 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 No NPRM 09/00/2023 No Businesses None No No No Gugandeep Kaur Regulatory Counsel 0910 Food and Drug Administration FDA 240 432-8301 gugandeep.kaur@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Silver Spring MD 20993