Title 21, Part 230 — Certification and Postmarketing Reporting for Designated Medical Gases
15 sections
Section 230.1
Scope of this part.
Section 230.2
Purpose.
Section 230.3
Definitions.
Section 230.50
General requirements for all submission types.
Section 230.65
Withdrawal by the applicant of a certification request before it is deemed granted.
Section 230.70
Supplements and other changes to a granted certification.
Section 230.72
Change in ownership of a granted certification.
Section 230.80
Annual report.
Section 230.100
FDA review of submissions.
Section 230.105
When a submission is deemed granted.
Section 230.150
Withdrawal or revocation of approval of an application.
Section 230.205
Field alert reports.
Section 230.210
General reporting requirements for designated medical gas adverse events.
Section 230.220
Human designated medical gas ICSR requirements.
Section 230.230
Animal designated medical gas adverse event reporting requirements.