Module 18 2021

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