Medical Gas Compliance Alert

Important Compliance Alert – Medical Gas Certification

This GAWDA Medical Gas Compliance Alert is to inform GAWDA members that the FDA has developed a process to remove the “unapproved medical gas” label from certain drug listings. Before this process was implemented, the drug listing for medical gases looked like this:

Now the drug listing can look like this:

Basically, it is now possible to remove the FDA safety warning from our medical gas drug listings.

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. Among other provisions, FDASIA:

1. Provided approval status for “designated medical gases”
2. Assured Drug User Fees are NOT applied to medical gases
3. Provided a framework to develop/revise medical gas regulations

Congress designated the core medical gases (and their “medically appropriate” mixtures) to have status similar to “approved” drugs. These gases are oxygen, nitrogen, air, helium, carbon dioxide, nitrous oxide and carbon monoxide. In order to grant approval status to these drug gases, the FDA uses an application and “certification” process in place of the very expensive “New Drug Application” (NDA). For the full text of the FDA instructions on this subject, see the draft “Guidance for Industry – Certification Process for Designated Medical Gases.” –

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332136.pdf

Download the full GAWDA Medical Gas Compliance Alert here.