21 CFR § 230.1 - Scope of this part.

---
identifier: "/us/cfr/t21/s230.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 230.1 - Scope of this part."
title_number: 21
title_name: "Food and Drugs"
section_number: "230.1"
section_name: "Scope of this part."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "230"
part_name: "CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360b, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1, 381."
regulatory_source: "89 FR 51777, June 18, 2024, unless otherwise noted."
cfr_part: "230"
---


# 230.1 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.