What Combination Products (Drug-Device) - Regulatory Governance & Lifecycle Requirements (2026) requires
Combination products (e.g., drug-eluting stents, prefilled syringes, digital therapeutics with drug components) require coordinated regulatory oversight under primary mode of action (PMOA). Manufacturers must comply with both device and drug/biologic requirements, including integrated quality systems, human factors engineering, stability studies, post-market surveillance, and dual reporting obligations to FDA/EMA. 2026 updates emphasize digital elements and AI integration.
Pillar: Medical & Healthcare · Authority: FDA Office of Combination Products, EMA, TGA · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-4
SHA-256 integrity: 47033f268255ec5d98a2ca69a94bdc8bab878660cba0ca349769e67b6bfbff3b
Primary Citations — 4 traced to source
- FDA 21 CFR Part 4 - Regulation of Combination Products
- FDA Guidance on Current Good Manufacturing Practice for Combination Products (2026)
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