FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care
From the article:
[...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA's disclosure to Congress is critical to a full policy discussion of the situation. [...]