In January, the FDA released a discussion paper on laboratory-developed tests (LDTs), designed to compile the feedback it has received on its LDT draft guidance and to examine a possible approach to LDT oversight. This approach would include focused oversight addressing only “new and significantly modified high and moderate risk LDTs,” excluding previously marketed LDTs. Oversight would be phased-in over four years. A new approach would broaden the definition of LDTs for “unmet needs,” or tests for which no approved alternative is available. As for evidence standards, the paper describes how the proprosed FDA and Centers for Medicare and Medicaid Services’ reviews would not overlap. The FDA would expand its work with third-party premarket review programs and the clinical community, and evidence of a test’s analytical and clinical validity would be made public. The FDA Quality System would also address the design and manufacture of LDT critical components, which are currently without oversight, assessing three aspects: design controls, acceptance activities, and corrective and preventive procedures.

Source: FDA