FDA Certification Process of Designated Medical Gases

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Draft — Not for Implementation 1 Certification Process for Designated Medical Gases 1

2 Guidance for Industry 3 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 I. INTRODUCTION 15 2

16 Title XI, Subtitle B of the Food and Drug Administration Safety and Innovation Act (FDASIA) 17 added sections 575 and 576 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), creating 18 a new certification process for approval of designated medical gases. Section 575 defines 19 “designated medical gas” to include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, 20 carbon monoxide, and medical air that meet the standards set forth in an official compendium. 21 Section 576 permits any person to file a request for certification of a medical gas as a designated 22 medical gas for certain indications specified in the statute. A designated medical gas for which a 23 certification is granted is deemed to have in effect an approved marketing application under 24 Section 505 of the FD&C Act (human drugs), Section 512 of the FD&C Act (animal drugs), or 25 both, depending on the type of certification requested and granted. This guidance explains how 26 the Food and Drug Administration (FDA) administers the certification process. Specifically, the 27 guidance discusses what products qualify as designated medical gases, who should submit a 28 certification request, what information should be submitted, how FDA will evaluate and act on 29 the request, and how FDA plans to enforce these new medical gas provisions. 30 31 Until a certification has been granted, anyone marketing a medical gas for human or animal drug 32 use without an approved application under section 505 or 512 of the FD&C Act is marketing an 3

33 unapproved new drug. See sections 505(a) and 512(a)(1)(A) of the FD&C Act. FDA expects 34 that persons or entities wishing to market designated medical gases for the indication or 35 indications specified in section 576(a)(3)(A)(i) will request certification from FDA, or ensure 1

This guidance has been prepared by the Office of Regulatory Policy, the Office of Pharmaceutical Quality, and the Office of Compliance in the Center for Drug Evaluation and Research (CDER) and the Office of New Animal Drug Evaluation in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration. 2

Public Law 112-144, 126 Stat. 993 (July 9, 2012). 3

See section IV below regarding who should request a certification and section VI below regarding the marketing of carbon monoxide for use in lung diffusion testing. 1

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