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21 CFR 230.1

§ 230.1 Scope of this part.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 230.1, § 230.1 Scope of this part, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86132
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.