[Ideas and Briefing about Regulatory Requirements for Laboratory Developed Tests in the US]

Zhongguo Yi Liao Qi Xie Za Zhi. 2022 Sep 30;46(5):534-537. doi: 10.3969/j.issn.1671-7104.2022.05.012.
[Article in 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.

Keywords: in vitro diagnostic devices; laboratory developed tests; regulatory requirements.

MeSH terms

  • Clinical Laboratory Services*
  • Laboratories
  • Reagent Kits, Diagnostic
  • United States
  • United States Food and Drug Administration

Substances

  • Reagent Kits, Diagnostic