A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.
Sign Up to like & getrecommendations! Published in 2020 at "Laboratory medicine"
DOI: 10.1093/labmed/lmaa086
Abstract: OBJECTIVE Regulations for clinical laboratories in the United States are complex. The goal of this review is to improve the clarity of laboratory-developed test (LDT) regulation to facilitate innovation. METHODS A literature and regulation review… read more here.
Keywords: regulations surrounding; level overview; high level; overview regulations ... See more keywords