Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products.
10.3969/j.issn.1671-7104.2023.05.019
- Author:
Jiaxin TIAN
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
combination product;
predicate product;
premarket pathway
- From:
Chinese Journal of Medical Instrumentation
2023;47(5):566-570
- CountryChina
- Language:Chinese
-
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.
