FDA Premarket Pathways for Combination Products.
10.3969/j.issn.1671-7104.2022.04.001
- Author:
Yuan LIN
1
Author Information
1. Potrero Medical, INC., Hayward, California, USA, 94545.
- Publication Type:Journal Article
- Keywords:
FDA;
combination products;
designation;
premarket pathway;
supervision
- MeSH:
Commerce;
Consumer Product Safety;
Direct-to-Consumer Advertising;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2022;46(4):355-360
- CountryChina
- Language:Chinese
-
Abstract:
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.