{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) acting as either protectants or preservatives, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree or risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from the use of the devices.","action":"Proposed amendment; proposed order.","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/2023/11/30/2023-26208.html","cfr_references":[{"chapter":null,"citation_url":null,"part":878,"title":21}],"citation":"88 FR 83802","comment_url":null,"comments_close_on":"2024-02-28","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed order must be submitted by February 28, 2024. FDA intends that, if a final order based on this proposed order is issued, anyone who wishes to market solid wound dressings, wound dressings formulated as a gel, cream, or ointment, and liquid wound washes containing medically important antimicrobials acting as either protectants or preservatives must submit a PMA prior to the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective. See section III for the effective date of any final order that may publish based on this proposed order. See section VI of this document for more information about submitting a PMA.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-3275"],"dockets":[{"supporting_documents":[{"title":"Reference 4 - WHO, Critically Important Antimicrobials for Human Medicine. 2018","document_id":"FDA-2023-N-3275-0007"},{"title":"Reference 3 - General and Plastic Surgery Devices Panel, “2016 Meeting Materials of the General and Plastic Surgery Advisory Panel--September 20-21, 2016”","document_id":"FDA-2023-N-3275-0006"},{"title":"Reference 2 - General and Plastic Surgery Devices Panel, “Brief Summary from the General and Plastic Surgery Devices Panel Meeting--August 25-26, 2005”","document_id":"FDA-2023-N-3275-0005"},{"title":"Reference 1 - General and Plastic Surgery Devices Panel, “Transcript of the FDA General and Plastic Surgery Devices Panel meeting--November 17, 1998”","document_id":"FDA-2023-N-3275-0004"},{"title":"List of References","document_id":"FDA-2023-N-3275-0003"}],"agency_name":"FDA","documents":[{"comment_count":9,"comment_start_date":"2023-11-30","updated_at":"2024-02-29T00:01:34.863-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-3275-0001","allow_late_comments":null,"id":"FDA-2023-N-3275-0001","comment_end_date":"2024-02-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":5,"id":"FDA-2023-N-3275","title":"Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes Containing Medically Important Antimicrobials"}],"document_number":"2023-26208","effective_on":null,"end_page":83808,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/30/2023-26208.xml","html_url":"https://www.federalregister.gov/documents/2023/11/30/2023-26208/effective-date-of-requirement-for-premarket-approval-applications-for-certain-solid-wound-dressings","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-26208?publication_date=2023-11-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-30/2023-26208/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":2664,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-30/pdf/2023-26208.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-26208.pdf?1701265523","publication_date":"2023-11-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/30/2023-26208.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 4 - WHO, Critically Important Antimicrobials for Human Medicine. 2018","document_id":"FDA-2023-N-3275-0007"},{"title":"Reference 3 - General and Plastic Surgery Devices Panel, “2016 Meeting Materials of the General and Plastic Surgery Advisory Panel--September 20-21, 2016”","document_id":"FDA-2023-N-3275-0006"},{"title":"Reference 2 - General and Plastic Surgery Devices Panel, “Brief Summary from the General and Plastic Surgery Devices Panel Meeting--August 25-26, 2005”","document_id":"FDA-2023-N-3275-0005"},{"title":"Reference 1 - General and Plastic Surgery Devices Panel, “Transcript of the FDA General and Plastic Surgery Devices Panel meeting--November 17, 1998”","document_id":"FDA-2023-N-3275-0004"},{"title":"List of References","document_id":"FDA-2023-N-3275-0003"}],"comments_count":9,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-3275","supporting_documents_count":5,"docket_id":"FDA-2023-N-3275","document_id":"FDA-2023-N-3275-0001","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes Containing Medically Important Antimicrobials","checked_regulationsdotgov_at":"2024-03-01T02:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":83802,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials","toc_doc":"Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials","toc_subject":null,"topics":["Medical devices"],"type":"Proposed Rule","volume":88}