What 21 CFR Part 4 - FDA Combination Products cGMP and Postmarketing Safety Reporting requires
21 CFR Part 4 sets the current good manufacturing practice (cGMP) requirements and postmarketing safety reporting requirements for combination products regulated by the U.S. Food and Drug Administration. A combination product comprises two or more regulated components (drug, device or biological product), and the manufacturer must determine the scope and applicable definitions before assessing compliance. The cGMP requirements of the constituent parts apply to the combination product, and a co-packaged or single-entity combination product may demonstrate compliance through a streamlined approach that satisfies a base set of one constituent part's cGMP plus specified provisions of the other. The manufacturer must determine the postmarketing safety reporting scope, submit the required reports for the combination product and its constituent parts, share required information with other constituent part applicants, submit reports in the required manner and place, and maintain the postmarketing safety reporting records.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4
SHA-256 integrity: 09f33fb3d0d234e2677afac77333271e784d49409985c16a2ecf60ab7bbd5c97
Primary Citations — 8 traced to source
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., and Public Health Service Act, 42 U.S.C. 262 - statutory authority
- 21 CFR Part 4, § 4.1 and § 4.2 - scope and definitions for combination product cGMP
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