FDA Premarket Pathways for Combination Products / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 355-360, 2022.
Article
in Chinese
| WPRIM
| ID: wpr-939746
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
United States
/
United States Food and Drug Administration
/
Commerce
/
Consumer Product Safety
/
Direct-to-Consumer Advertising
Type of study:
Practice guideline
Country/Region as subject:
North America
Language:
Chinese
Journal:
Chinese Journal of Medical Instrumentation
Year:
2022
Type:
Article
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