[Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products]

Jiaxin Tian

doi:10.3969/j.issn.1671-7104.2023.05.019

[Analysis of FDA's Review Concerns for Premarket Pathways and Predicate Product Selection of Device-led Combination Products]

Zhongguo Yi Liao Qi Xie Za Zhi. 2023 Sep 30;47(5):566-570. doi: 10.3969/j.issn.1671-7104.2023.05.019.

[Article in Chinese]

Author

Jiaxin Tian¹

Affiliation

¹ Center for Medical Device Evaluation, NMPA, Beijing, 100081.

PMID: 37753899
DOI: 10.3969/j.issn.1671-7104.2023.05.019

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.

Keywords: combination product; predicate product; premarket pathway.

Publication types

English Abstract