Part 230 — Certification and Postmarketing Reporting for Designated Medical Gases
Current through Sep 8, 2026
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.
Source: 89 FR 51777, June 18, 2024, unless otherwise noted.
Sections
- § 230.1 Scope of this part.
- § 230.2 Purpose.
- § 230.3 Definitions.
- § 230.50 General requirements for all submission types.
- § 230.65 Withdrawal by the applicant of a certification request before it is deemed granted.
- § 230.70 Supplements and other changes to a granted certification.
- § 230.72 Change in ownership of a granted certification.
- § 230.80 Annual report.
- § 230.100 FDA review of submissions.
- § 230.105 When a submission is deemed granted.
- § 230.150 Withdrawal or revocation of approval of an application.
- § 230.205 Field alert reports.
- § 230.210 General reporting requirements for designated medical gas adverse events.
- § 230.220 Human designated medical gas ICSR requirements.
- § 230.230 Animal designated medical gas adverse event reporting requirements.