Per 21 CFR 3.2(e), a combination product is composed of two or more different types of medical products (drug, device, biologic) that are physically, chemically, or otherwise combined or co-packaged. The definition covers single-entity products (such as a drug-eluting stent), co-packaged products, and cross-labeled products sold separately. FDA's Office of Combination Products assigns a lead center based on the primary mode of action, and manufacturers must meet current good manufacturing practice requirements for each constituent part under 21 CFR Part 4.

Why it matters

FDA assigns a lead center based on the product's primary mode of action. Combination products must comply with both drug GMPs and device QSR/QMSR via streamlined cGMP requirements at 21 CFR Part 4.

Common pitfalls

•Failing to identify a product as a combination product early in development can lead to significant regulatory delays.
•Incorrectly determining the primary mode of action may result in submission to the wrong lead center, causing rework.
•Assuming that only one set of GMPs applies can result in non-compliance with applicable regulations for both components.
•Overlooking the need for a comprehensive quality management system that integrates requirements for all constituent parts is a common pitfall.
•Underestimating the complexity of post-market surveillance and reporting for combination products can lead to compliance issues.

Sources

Combination Products · FDA
21 CFR Part 4 · eCFR
European Commission - Medical Devices · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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