Combination Product
A combination product combines a medical device with a drug or biologic — such as a prefilled syringe or drug-eluting stent — and is regulated according to its primary mode of action.
What is a combination product?
The U.S. definition at 21 CFR 3.2(e), explained on the FDA's combination-product pages, covers products composed of two or more regulated constituent types — drug, device and/or biological product. They may be physically combined, co-packaged or separately distributed but specifically cross-labeled for use together. Examples include drug-eluting stents, prefilled autoinjectors and kits containing a medicinal product with a delivery device.
Who reviews a combination product at the FDA?
Lead-center assignment generally follows the primary mode of action (PMOA), the mode that provides the most important therapeutic action of the combination product. CDRH, CDER or CBER leads according to the constituent responsible for that action, with consultation from the other center or centers. When classification or assignment is uncertain, a sponsor may use the Office of Combination Products' Request for Designation process. Applicable cGMP obligations also depend on the constituent parts and manufacturing arrangement.
How does the EU treat drug-device combinations?
The EU does not use one equivalent third category. The regulatory framework depends on principal action and product configuration. For a single integral medicine-led combination covered by the second subparagraphs of MDR Articles 1(8) or 1(9), the marketing-authorization dossier must address the device part. Under Article 117, it includes relevant conformity results: where the device is not already CE marked and would require notified-body certification if marketed separately, a notified-body opinion on applicable general safety and performance requirements is required. Non-sterile, non-measuring Class I cases are treated differently. Device-led products incorporating an ancillary medicinal substance follow the MDR consultation route.
Why do combination products deserve early strategy work?
The lead framework and configuration affect evidence ownership, human-factors work, quality-system interfaces, labeling, change control and post-market reporting. These decisions also differ between the United States and European Union. Mapping each constituent, its action and its commercial presentation early is safer than assuming that one market's combination-product label determines the other market's pathway.
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