FDA Draft Guidance on Medical Gases Certification Process

Detected February 27th, 2026

Summary

The FDA has issued draft guidance for industry on the certification process for designated medical gases. This guidance explains the certification process and annual reporting requirements, aiming to reduce regulatory burden for the medical gas industry. Comments are due by April 13, 2026.

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What changed

The Food and Drug Administration (FDA) has released a draft guidance document titled "Certification Process for Designated Medical Gases" for public comment. This guidance details the FDA's administration of the certification process for designated medical gases (DMGs), including product qualification, submission requirements, and evaluation procedures, as well as annual reporting obligations. It aims to reflect new and revised regulations intended to reduce the regulatory burden on the medical gas industry and revises a previous draft guidance from November 2015.

This document is a draft and is open for public comment until April 13, 2026. Companies involved in the production or distribution of designated medical gases should review the guidance to understand the proposed certification and reporting requirements. Submitting comments by the deadline is crucial for the FDA to consider feedback before finalizing the guidance. Failure to comply with future final requirements could result in regulatory action.

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04/13/2026

Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-1197

Docket Number: FDA-2012-D-1197 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Veterinary Medicine The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Certification Process for Designated Medical Gases.”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.