Certification Process for Designated Medical Gases; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Certification Process for Designated Medical Gases."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 This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.