What US FDA Combination Products - 21 CFR Part 3: Device/Drug/Biologic Combination Classification, Primary Mode of Action (PMOA) Determination, Intercenter Agreement (ICA) Assignment, Integrated Review Process, NDA/PMA/BLA Pathway Selection and Post-Market Surveillance Responsibilities requires
This regulation governs the classification, jurisdictional assignment, and regulatory pathway for combination products consisting of drugs, devices, and/or biological products under 21 CFR Part 3…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.1 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-3
SHA-256 integrity: 12e8292bef0c91aca33016556ec69ef25e6ad48bb152ce8d12d0cffd471ee244
Primary Citations — 5 traced to source
- Combination Product Definition and Combination Product Types, https://www.fda.gov/combination-products, Learn More, 2026
- Guidance & Regulatory Information, https://www.fda.gov/combination-products, Guidance & Regulatory Information, 2026
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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- Discovery (free): /api/v1/nodes/us-fda-combination-products-21-cfr-3.json — 6-field metadata
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- Canonical URL: https://bidda.com/intelligence/us-fda-combination-products-21-cfr-3
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