GUIDANCE DOCUMENT
Certification Process for Designated Medical Gases Draft Guidance for Industry February 2026
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2012-D-1197
- Docket Number:
- FDA-2012-D-1197
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Veterinary Medicine
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Certification Process for Designated Medical Gases.”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 This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance of the same name issued in November 2015, which was withdrawn on December 18, 2025.