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Certification Process of Designated Medical Gases November 2015


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Title XI, Subtitle B of the Food and Drug Administration Safety and Innovation Act (FDASIA)2 16 added sections 575 and 576 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), creating 17 a new certification process for approval of designated medical gases. Section 575 defines 18 “designated medical gas” to include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, 19 carbon monoxide, and medical air that meet the standards set forth in an official compendium. 20 Section 576 permits any person to file a request for certification of a medical gas as a designated 21 medical gas for certain indications specified in the statute. A designated medical gas for which a 22 certification is granted is deemed to have in effect an approved marketing application under 23 Section 505 of the FD&C Act (human drugs), Section 512 of the FD&C Act (animal drugs), or 24 both, depending on the type of certification requested and granted. This guidance explains how 25 the Food and Drug Administration (FDA) administers the certification process. Specifically, the 26 guidance discusses what products qualify as designated medical gases, who should submit a 27 certification request, what information should be submitted, how FDA will evaluate and act on 28 the request, and how FDA plans to enforce these new medical gas provisions.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-1197.

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