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CATEGORY: CLASSIFICATION
Combination Product
A product that combines a medical device with a drug, biologic, or both. In the US, the FDA assigns a primary mode of action to determine which center (CDRH, CDER, or CBER) leads the review. EU MDR Article 1(8-9) addresses drug-device combinations.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Combination products combine drug/device, biologic/device, or drug/biologic constituents (e.g., prefilled syringes, drug-eluting stents). Jurisdiction and primary mode of action determine lead center and submission type.
PROCESS / STEPS
- Request designation/RFD when primary mode of action is unclear.
- Map constituent requirements (cGMP for drugs, QSR/QMSR for devices, etc.).
- Plan integrated clinical and CMC/device performance evidence.
- Align labeling, postmarket reporting, and change control across constituents.
EXAMPLES
- An autoinjector with a biologic is typically a combination product with CDER/CBER lead depending on PMOA.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Combination Product across 27 authorities in real time.
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