WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory developed tests (LDTs) that motivated the federal Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to declare its intention “to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk)” in a …
FDA Issues Memo to Reclassify Many High Risk IVD Assays Read More »
