This summary provides an overview of a regulatory struggle that has spanned nearly half a century. Since the 1970s, the industry has been actively lobbying the FDA and Congress to treat medical gases differently from other drug products. After decades of advocacy, a final rule was passed that includes some of the concessions the industry has been seeking. However, it also maintains certain reporting and safety provisions that the FDA considers crucial.
Medical gases, including oxygen and medical air, are crucial in diverse healthcare environments, ranging from hospitals to home care settings. The details about the scope of use and regulatory changes are in the full article, access to which requires filling out a form.
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