21 C.F.R. § 230.1

Current through October 31, 2024
Section 230.1 - [Effective 12/18/2025] Scope of this part

This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of certifications to market designated medical gases under sections 575 and 576 of the Federal Food, Drug, and Cosmetic Act, as well as amendments and supplements to those certifications. This part also sets forth the postmarketing safety reporting requirements for designated medical gases.

21 C.F.R. §230.1

89 FR 51777 , 12/18/2025