RESUMEN
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.
RESUMEN
Combination products face unique R&D, manufacturing, clinical, and regulatory challenges compared to individual devices, drugs, or biological products. Based on the interpretation of the relevant policies and the latest principles of combination products, this paper expounds the FDA's guidance, application trends, and application strategies for the pre-market pathways of combination products, with a view to providing relevant information for Chinese researchers and manufacturers when they start to entry the United States market.