The FDA has created new rules specifically for medical gases to improve how they are labeled, manufactured, certified, and reported for safety. These rules aim to address the unique characteristics of medical gases and ensure that they meet safety and quality standards.
Under the new rules, manufacturers of medical gases will be required to follow four essential provisions. First, labels must clearly state the ingredients and the amount of gas in each container. All medical gases, whether for humans or animals, need standardized labels. Warning labels are required for certain gases, like medical air and carbon monoxide. New labels include a warning about the dangers of smoking, vaping, and open flames near oxygen containers. Labels should help users return containers to the owner and direct quality issues to the right place. The definition of “portable cryogenic medical gas container” has been clarified for better labeling.
Second, new rules for how medical gases should be manufactured, processed, packed, and stored clarify that medical gases must follow cGMP (Current Good Manufacturing Practice) similar to those for drugs but adapted for medical gases. Specifically, special cleaning requirements are included since medical gases are made in sealed systems. Containers must have gauges to show if they have enough gas. There are no time limits on production since medical gases don’t expire or degrade like other drugs. Improperly stored medical gases can be salvaged if their quality hasn’t been compromised.
Third, the FDA has outlined a clearer certification process for medical gases. Companies must follow a specific process to request certification and report annually. The rules are similar to the FDA’s 2015 draft guidance on the certification process. Annual reports must now be submitted based on the calendar year.
Lastly, per the new post-market safety reporting requirements for medical gases, companies must submit field alert reports (FARs) and adverse event reports within specific timelines. Serious adverse events for human-use gases must be reported within 15 days. Reports must be submitted electronically unless a waiver is granted. For animal-use gases, serious adverse event reports also have a 15-day reporting requirement. Records of adverse events must be kept and procedures documented to protect patient privacy.
The FDA’s new rules are designed to make the regulation of medical gases more efficient and ensure they meet safety and quality standards. These changes reflect feedback from industry experts and aim to provide clarity and consistency in how medical gases are managed from production to post-market safety.
