Unpacking Averages: Assessing FDA’s Performance Categorizing New Diagnostic Tests Under CLIA
Health Law Advisor
APRIL 5, 2022
This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). I use the word “may” there because the FDA data set is inadequate to support a firm conclusion. of that guidance, and FDA refers to these as “concurrent.”
52 
Let's personalize your content