{"abstract":"The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified devices as devices requiring premarket notification (510(k) requirements), with the product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product codes for these proposed classifications upon finalization of this classification action. FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III. In addition, FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals, into class II (subject to special controls and 510(k) requirements).","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/11/30/2023-26209.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"878","title":21}],"citation":"88 FR 83774","comment_url":null,"comments_close_on":"2024-02-28","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submit by February 28, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-3392"],"dockets":[{"supporting_documents":[{"title":"Reference 53 - Luqman A., M. Muttaqin, S. Yulaipi, et al., “Trace Amines Produced by Skin Bacteria Accelerate Wound Healing in Mice,” Communications Biology","document_id":"FDA-2023-N-3392-0055"},{"title":"Reference 51 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular and Molecular Medicine","document_id":"FDA-2023-N-3392-0053"},{"title":"Reference 49 - Linehanm J., O. Harrison, S. Han, et al., “Non-Classical Immunity Controls Microbiota Impact on Skin Immunity and Tissue Repair,” Cell","document_id":"FDA-2023-N-3392-0051"},{"title":"Reference 47 - Saad A., E. Salazar, L. Allen, et al., “Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial,” American Journal of Perinatology","document_id":"FDA-2023-N-3392-0049"},{"title":"Reference 46 - Serena T., L. Serena, O. Al-Jalodi, et al., “The Efficacy of Sodium Hypochlorite Antiseptic: A Double-Blind, Randomised Controlled Pilot Study,” Journal of Wound Care","document_id":"FDA-2023-N-3392-0048"},{"title":"Reference 41 -  Choi Y., K. Campbell, C. Levek, et al., “Antibiotic Ointment Versus a Silver-Based Dressing for Children With Extremity Burns: A Randomized Controlled Study,” Journal of Pediatric Surgery","document_id":"FDA-2023-N-3392-0043"},{"title":"Reference 39 - FDA, “General and Plastic Surgery Devices; Classification of the Nonresorbable Gauze/Sponge for External Use, the Hydrophilic Wound Dressing, the Occlusive Wound Dressing, and the Hydrogel Wound Dressing,” 64 FR 53927, October 5, 1999","document_id":"FDA-2023-N-3392-0041"},{"title":"Reference 38 - FDA, “Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff,” September 2017","document_id":"FDA-2023-N-3392-0040"},{"title":"Reference 37 - Burke T., M. Rupp, P. Fey, “Staphylococcus Epidermidis,” Trends in Microbiology","document_id":"FDA-2023-N-3392-0039"},{"title":"Reference 33 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular And Molecular Medicine","document_id":"FDA-2023-N-3392-0035"}],"agency_name":"FDA","documents":[{"comment_count":77,"comment_start_date":"2023-11-30","updated_at":"2024-03-19T01:01:35.305-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-3392-0001","allow_late_comments":null,"id":"FDA-2023-N-3392-0001","comment_end_date":"2024-02-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":57,"id":"FDA-2023-N-3392","title":"Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Creams, or Ointment, and Liquid Wound Washes"}],"document_number":"2023-26209","effective_on":null,"end_page":83802,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/30/2023-26209.xml","html_url":"https://www.federalregister.gov/documents/2023/11/30/2023-26209/medical-devices-general-and-plastic-surgery-devices-classification-of-certain-solid-wound-dressings","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-26209?publication_date=2023-11-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-30/2023-26209/mods.xml","not_received_for_publication":null,"page_length":29,"page_views":{"count":7963,"last_updated":"2026-10-22 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-30/pdf/2023-26209.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-26209.pdf?1701265528","publication_date":"2023-11-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/30/2023-26209.txt","regulation_id_number_info":{"0910-A126":null},"regulation_id_numbers":["0910-A126"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 53 - Luqman A., M. Muttaqin, S. Yulaipi, et al., “Trace Amines Produced by Skin Bacteria Accelerate Wound Healing in Mice,” Communications Biology","document_id":"FDA-2023-N-3392-0055"},{"title":"Reference 51 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular and Molecular Medicine","document_id":"FDA-2023-N-3392-0053"},{"title":"Reference 49 - Linehanm J., O. Harrison, S. Han, et al., “Non-Classical Immunity Controls Microbiota Impact on Skin Immunity and Tissue Repair,” Cell","document_id":"FDA-2023-N-3392-0051"},{"title":"Reference 47 - Saad A., E. Salazar, L. Allen, et al., “Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial,” American Journal of Perinatology","document_id":"FDA-2023-N-3392-0049"},{"title":"Reference 46 - Serena T., L. Serena, O. Al-Jalodi, et al., “The Efficacy of Sodium Hypochlorite Antiseptic: A Double-Blind, Randomised Controlled Pilot Study,” Journal of Wound Care","document_id":"FDA-2023-N-3392-0048"},{"title":"Reference 41 -  Choi Y., K. Campbell, C. Levek, et al., “Antibiotic Ointment Versus a Silver-Based Dressing for Children With Extremity Burns: A Randomized Controlled Study,” Journal of Pediatric Surgery","document_id":"FDA-2023-N-3392-0043"},{"title":"Reference 39 - FDA, “General and Plastic Surgery Devices; Classification of the Nonresorbable Gauze/Sponge for External Use, the Hydrophilic Wound Dressing, the Occlusive Wound Dressing, and the Hydrogel Wound Dressing,” 64 FR 53927, October 5, 1999","document_id":"FDA-2023-N-3392-0041"},{"title":"Reference 38 - FDA, “Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff,” September 2017","document_id":"FDA-2023-N-3392-0040"},{"title":"Reference 37 - Burke T., M. Rupp, P. Fey, “Staphylococcus Epidermidis,” Trends in Microbiology","document_id":"FDA-2023-N-3392-0039"},{"title":"Reference 33 - Leonel C., I. Sena, W. Silva, et al., “Staphylococcus Epidermidis Role in the Skin Microenvironment,” Journal of Cellular And Molecular Medicine","document_id":"FDA-2023-N-3392-0035"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI26/medical-devices-general-and-plastic-surgery-devices-classification-of-certain-solid-wound-dressings-","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"},"comments_count":77,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-3392","supporting_documents_count":57,"docket_id":"FDA-2023-N-3392","document_id":"FDA-2023-N-3392-0001","regulation_id_number":"0910-AI26","title":"Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Creams, or Ointment, and Liquid Wound Washes","checked_regulationsdotgov_at":"2024-03-20T01:00:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":83774,"subtype":null,"title":"Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes","toc_doc":"General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Proposed Rule","volume":88}