FDA LDT Proposal Under the Microscope
The controversy over the regulation of laboratory developed
tests (LDTs) heated up this month in a public forum organized by the Food and Drug Administration (FDA)
to discuss its proposal for a risk-based approach to regulate these
assays. The Agency’s issuance last fall of a proposed framework for the
regulation of LDTs signaled the end of the FDA's long-standing policy
of "enforcement discretion."