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. It requires sponsors to determine the primary mode of action (PMOA) and follow Intercenter Agreement (ICA) procedures when multiple FDA centers are involved, as defined in the Combination Product guidance documents.
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: 5274fbac279307f64011d07e118f6adcca5d7eac6c310290c25b75c26fc4e78e
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
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