FDA Medical Gas Guidelines

Early in the year, FDA is expected to publish for public comment its long anticipated updated FDA Medical Gas Guidelines. This will be the first formal update to FDA's guidelines since they were originally published in 1989. At the time of this article's writing, there is only speculation on what the new guidelines will actually contain. However, with 14 years since formal guidelines were last published by FDA, and three years since the last update of FDA's informal medical gas guidance publication Fresh Air, some significant changes are anticipated. We should expect to see new requirements being proposed for producing medical gases, as well as changes to existing requirements that range from slight modifications to extensive revisions.

The regulatory process followed by government agencies ensures that Federal agencies proposing new or modified regulations provide the regulated industry, along with the public, an opportunity to have a voice in shaping regulations and requirements. This is known as the notice and comment process, and through this process, interested parties have the chance to provide comments and propose suggested changes back to the agency promulgating the regulations. Individuals and individual companies, as well as industry associations, are able to participate in this process. In recent years, FDA has not made use of the notice and comment process when they have changed their requirements for manufacturing medical gases. GAWDA and CGA have actively sought to have FDA begin using this process, and welcome this opportunity to have a public dialogue on the requirements for producing medical gases.

Industry associations play a key role in the process of notice and comment. As the regulatory agency reviews and considers the comments provided, those comments and proposed changes which represent an industry position can potentially have a more significant impact on the agency's deliberation of received comments than comments submitted by an individual or a single company. Representing the gases and welding distributors position on issues to regulatory agencies is in fact one of the key missions of GAWDA.

GAWDA and CGA — Association Comments
The medical gases industry is predominantly represented by two industry associations, the Gases and Welding Distributors Association (GAWDA) and the Compressed Gas Association (CGA). These two associations have worked together for years on technical issues related to medical gases issues, as well as coordinating discussions at executive management levels. This close collaboration between the two associations has effectively given the industry one powerful voice when interacting with FDA on medical gas issues.

There are two primary channels of interaction established between the CGA and GAWDA. At the executive and management level is the CGA FDA Executive Council. This council coordinates policy level discussions on medical gas issues. A GAWDA representative has been part of this council since its inception in 1999. In 2002, Jim Madison of Prest-O-Sales & Service succeeded Chip Valentine of nexAir as the GAWDA representative to this council.

At the technical committee and working group level, B&R Compliance Associates is now the key liaison between GAWDA and CGA. B&R is a member of the CGA Medical Gas and Equipment Committee as well as all associated key task forces. This ensures that the CGA committees are aware of the GAWDA position and have the benefit of input from the independent distributor perspective on developing medical gas compliance issues.

Notice and Comment Process
The notice and comment process provides a defined timeline for comments to be returned, which in this case is 60 days. The agency may agree to extend this time frame to allow the industry more time to review and respond. Food and Drug Administration officials, however, have promised industry executives during recent meetings that the medical gases industry will have the time needed to engage in a full review and discussion with FDA on the new guidelines. This is not to say that the comment processes can go on indefinitely. The medical gases community must undertake a concentrated and focused effort to review the new guidelines, develop an industry consensus response, and provide those comments back to FDA as quickly as is reasonably possible. Instead of taking what is typically years to develop an industry position on a regulatory issue, the medical gas community will have just a few short months. This is a daunting task when you consider the size, complexity and diversity of our industry.

Members submitting comments to FDA should keep in mind that FDA is a science-based organization. Comments supported by technical facts and data will have the most impact with the agency. Comments that incorporate arguments such as “it has never happened before” will have a minimal impact on the agency's review and deliberation process.

Once the comment period has elapsed, the FDA will review and consider all comments that have been submitted. After deliberation, they will publish the final guidelines with any changes they make incorporated. We expect the agency to provide a review of all comments submitted and their response to those comments.

Develop a Transition Plan
Following FDA publication of the new Medical Gas Guidelines, even while still in draft form, GAWDA members should expect to see FDA inspectors using these new guidelines to conduct site inspections. The industry should also anticipate that inspection activity in the medical gas industry will increase after the new guidelines are published.

Once the new requirements are revealed, medical gas firms are advised to begin consideration and development of a transition plan for their business to meet any new or changed requirement. Transition plans should include revising operating procedures and providing training to impacted employees, as well as documenting all these activities. Once the final guidance document is published, firms will be expected to be in full compliance during FDA site inspections.

Following publication of the new FDA guidelines, GAWDA will be providing all program members updates to the GAWDA SOP manual and all relevant compliance materials. These updates will incorporate the new requirements and provide the procedures needed to be in compliance.