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Part 230
FEDERAL · 21 CFR
Part 230 — Certification and Postmarketing Reporting for Designated Medical Gases
15 sections · Title 21: Food and Drugs
§ 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.