MedTech Dive May 3, 2024
Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.
The Food and Drug Administration’s final rule solidifying its authority over laboratory developed tests (LDTs) marks a major shift in the regulation of the diagnostics industry.
The rule makes clear that the subset of tests, made and run within a single lab, are subject to the same federal requirements as medical devices, including adverse event reporting, labeling standards and premarket review. Tests made outside labs are already regulated in this way.
Over the next four years, the FDA will phase out a less-stringent approach to regulating LDTs that it has used for roughly half a century, on the...
Today's Sponsors
Today's Sponsor