Compliance change you need to know – FDA requiring distributors and producers to comply with new regs


After a relatively inactive two years where these gases are concerned, the Food and Drug Administration (FDA) is again focusing its attention on medical gas requirements.

In June, the FDA released a long-awaited update to the 2003 medical gas guidance document, and the agency has recently begun notifying gas manufacturers of changes expected in its 2018 facility registrations. This article will focus on that recent FDA activity and what it means to medical gas producers and distributors.

In 2003 the FDA released a comprehensive medical gas guidance document. While never finalized, this document, outside of a small group of issues, evolved into the definitive set of requirements for medical gas manufacturers. It also became the standard against which the FDA inspected facilities.

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