Ideas and Briefing about Regulatory Requirements for Laboratory Developed Tests in the US.
10.3969/j.issn.1671-7104.2022.05.012
- Author:
Zhaozhao HAN
1
;
Yang ZHAO
2
;
Yunfeng L
1
;
Jinchun DONG
1
;
Gang DENG
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
2. National Medical Products Administration, Beijing, 100037.
- Publication Type:Journal Article
- Keywords:
in vitro diagnostic devices;
laboratory developed tests;
regulatory requirements
- MeSH:
Clinical Laboratory Services;
Laboratories;
Reagent Kits, Diagnostic;
United States;
United States Food and Drug Administration
- From:
Chinese Journal of Medical Instrumentation
2022;46(5):534-537
- CountryChina
- Language:Chinese
-
Abstract:
As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
