FDA Deficient in Capacity to Regulate Laboratory-Developed Tests, Senators Say

The FDA does not have the capacity to regulate the tens of thousands of laboratory-developed tests currently being used across the country, senators said during a committee hearing on the future of regulation in the age of precision medicine.

“Is there anybody here that believes that the FDA architecture or the FDA talent exists today to be able to handle the processing of an [LDT] application or an approval three years from now?” asked Sen. Richard Burr (R-N.C.), during hearing before the Senate Health, Education, Labor and Pensions Committee.

Currently, most tests that are developed and used within a single facility are regulated by the Centers for Medicare & Medicaid Services, under the Clinical Laboratory Improvement Amendments (CLIA). They can include in vitro diagnostics, blood tests, and assays evaluating whether a patient will respond to a specific drug. — Conor Hale