21 CFR Part 230
PART 230—CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES
- PART 230—CERTIFICATION AND POSTMARKETING REPORTING FOR DESIGNATED MEDICAL GASES
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter C—Drugs: General
- Subpart A—General Provisions
- § 230.1 Scope of this part.
- § 230.2 Purpose.
- § 230.3 Definitions.
- Subpart B—Certification of Designated Medical Gases
- § 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.
- Subpart C—Postmarketing Quality and Safety Reporting
- § 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.
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