{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Certification Process for Designated Medical Gases.\" This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs). Specifically, the guidance discusses what products qualify as DMGs, who must submit a certification request, what information must be submitted, and how FDA will evaluate and act on the request. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2026/02/12/2026-02789.html","cfr_references":[],"citation":"91 FR 6645","comment_url":null,"comments_close_on":"2026-04-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 13, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by April 13, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-1197"],"dockets":[{"supporting_documents":[{"title":"Compressed Gas Association and GAWDA - Comment re FDA-2012-D-1197-0007","document_id":"FDA-2012-D-1197-0008"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-02-12","updated_at":"2026-02-12T08:58:15.289-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2012-D-1197-0013","allow_late_comments":false,"id":"FDA-2012-D-1197-0013","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2012-D-1197","title":"Draft Guidance for Industry on Certification of Designated Medical Gases; Availability"}],"document_number":"2026-02789","effective_on":null,"end_page":6647,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/02/12/2026-02789.xml","html_url":"https://www.federalregister.gov/documents/2026/02/12/2026-02789/certification-process-for-designated-medical-gases-draft-guidance-for-industry-availability-agency","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-02789?publication_date=2026-02-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-02-12/2026-02789/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":246,"last_updated":"2026-05-31 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-12/pdf/2026-02789.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-02789.pdf?1770817508","publication_date":"2026-02-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/02/12/2026-02789.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Compressed Gas Association and GAWDA - Comment re FDA-2012-D-1197-0007","document_id":"FDA-2012-D-1197-0008"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-D-1197","supporting_documents_count":1,"docket_id":"FDA-2012-D-1197","document_id":"FDA-2012-D-1197-0013","regulation_id_number":null,"title":"Draft Guidance for Industry on Certification of Designated Medical Gases; Availability","checked_regulationsdotgov_at":"2026-02-13T17:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6645,"subtype":null,"title":"Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Certification Process for Designated Medical Gases","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}