FDA Draft Guidance on Medical Gases Certification Process

The Food and Drug Administration (FDA) has released a draft guidance document titled "Certification Process for Designated Medical Gases" for public comment.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new and revised regulations intended to reduce the regulatory burden on the medical gas industry and revises a previous draft guidance from November 2015.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.