Combination Product
Product comprised of two or more regulated components - e.g., drug-device, biologic-device.
Definition
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.What this means in practice
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.Examples
- A pre-filled syringe combining a drug and a delivery device is a common combination product.
- Drug-eluting stents, which release medication to prevent restenosis, are another example of a combination product.
- Insulin pens, which integrate a drug-delivery system with insulin, exemplify a drug-device combination.
- •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.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFormal mechanism to obtain a binding FDA decision on which Center will regulate a product.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
De Novo & Breakthrough Pathways
· From this learning pathFDA's most stringent device marketing application, required for high-risk Class III devices.
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
Where this term appears across MedTech Terms.
- De Novo & Breakthrough PathwaysLesson 11 of 11
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Combination ProductsTier 2 VerifiedFDAfda.gov
- 221 CFR Part 4Tier 1 VerifiedeCFRecfr.gov
- 3European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.