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类别: CLASSIFICATION
组合产品
将医疗器械与药物、生物制品或两者相结合的产品。在美国，FDA指定主要作用方式以确定由哪个中心（CDRH、CDER或CBER）主导审查。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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.
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SOURCES
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