Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Combination products

US ● Legal definition in 21 CFR 3.2 (e) ● Includes four categories

– Single entity combination product – Co-packaged combination product – Cross-labelled combination product – Cross-labelled combination product (investigational) ● FDA process for jurisdiction determination (CDER, CBER, CDRH) based on primary mode of action

– Office of Combination Products – Request for Designation/pre-RFD

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Combination products

EU ● No legal definition ● Regulatory jurisdiction based on primary action – Pharmacological = MEDICINE regulated by EMA/national medicines agencies – Prefilled syringe – Disposable insulin pen – Physical = DEVICE regulated by notified bodies on behalf of competent authorities – Drug-eluting stent – Refillable insulin pen

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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