Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products / 中国医疗器械杂志

ABSTRACT

By discussing the relevant requirements of the Principles of Premarket Pathways for Combination Products Guidance, this study analyzes FDA's review concerns for premarket pathways and predicate product selection of device-led combination products' five typical situations, in order to provide reference for Chinese manufacturers and investigators in device-led combination products registration.