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.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.
Primary references
3 sources- 1
Combination ProductsVerifiedFDAfda.gov
- 2
21 CFR Part 4VerifiedeCFRecfr.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.