In a new final rule, FDA carves out a regulatory niche for medical gases


Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Nearly fifty years later, a final rule has made concessions industry has long been calling for, but retains reporting and safety provisions the agency deems important.

Medical gases such as oxygen and medical air are widely used in a variety of healthcare and home/community settings.

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