Analysis of clinical evaluation requirements for peripheral blood thrombolysis devices of US Food and Drug Administration
10.3969/j.issn.1672-8270.2025.02.028
- VernacularTitle:美国食品药品监督管理局外周血栓清除器械临床评价要求分析
- Author:
Weilu CHENG
1
;
Lingdan XU
;
Zehua WANG
;
Yinghui LIU
Author Information
1. 国家药品监督管理局医疗器械技术审评中心 北京 100081
- Publication Type:Journal Article
- Keywords:
Peripheral blood thrombolysis device;
Lung blood thrombolysis apparatus;
Medical devices;
Clinical evaluation
- From:
China Medical Equipment
2025;22(2):154-160
- CountryChina
- Language:Chinese
-
Abstract:
[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.
