The US Food and Drug Administration (FDA) has released a new draft guidance document aimed at providing clarity to the process by which certain designated medical gases become certified by regulators.
Certification Process for Designated Medical Gases, released on 14 December 2012 and endorsed by FDA's Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM), is the result of the FDA Safety and Innovation Act (FDASIA) of 2012, which created a new regulatory process for approving medical gases intended for human or animal use.
That process is set to go into effect on 5 January 2012, and the gases already designated under the FDASIA statute include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide and "medical air that meet the standards set forth in an official compendium," FDA explained.
Section 576 of FDASIA permits anyone to request that FDA certify designated medical gases for "certain indications listed in the [FDASIA] statute," and FDA's draft guidance is aimed at determining which products would qualify under the certification process, what that process will look like and how the agency will exercise its enforcement discretion over medical gases.
Entities looking to certify their products should submit the form attached to the guidance to FDA. The form requests that sponsors include a description of the gas, identifying information about the sponsor and manufacturing facility, and any other "information deemed appropriate," FDA explained.
Though the gases are technically regulated as drug products, the process by which they obtain clearance is more similar in nature to that used by a Class I medical device than by a pharmaceutical product in that it calls for adherence to an established standard (also similar to FDA's regulation of over-the-counter (OTC) medicines). Those standards must be set by an "official compendium" such as the US Pharmacopoeia (USP), the National Formulary (NF) or the Homeopathic Pharmacopeia of the US.
Within 60 days of filing an application, a medical gas will be granted certification barring the presence any one of three conditions: if the gas for which approval is sought is not a designated medical gas, if the sponsor's request lacks the information necessary to make a decision, and/or if the product would pose a risk to public health. Any sponsor of a denied application will be given one month of leeway in which to refile a certification request before FDA takes enforcement action against the company if it continues to market a medical gas.
FDA notes that only the first person or entity to market a gas will be required to request certification for that gas. "In most cases, this will be the original manufacturer of the gas, that is, the person or entity that initially produces the gas by chemical reaction, physical separation, compression of atmospheric air, or other means," FDA explained. The guidance did not mention a specific process for subsequent marketers of medical gases, or whether they would be required to have any information cleared through the agency.
Products will, however, be required to bear a specific warning label indicating how to use the particular gas safely. Carbon dioxide, helium and nitrous oxide are governed by the terms of 21 CFR 201.161(a); Nitrogen, medical air and carbon monoxide are meanwhile-in the absence of formal regulation-advised to follow the same 161(a) regulation, while oxygen should bear the warning set forth in 576(b)(2)(B).
"If these warning statements are used, FDA intends to exercise enforcement discretion over noncompliance with sections 503(b)(4) and 502(f) of the Federal Food, Drug and Cosmetic Act," the agency explained.
Any products being marketed without having first been certified may be subject to FDA's regulatory enforcement discretion, the draft guidance notes.