A new discussion paper from the Food and Drug Administration (FDA) shows how the agency envisions regulating laboratory developed tests (LDT) under a new presidential administration. FDA wants further stakeholder discussion, and to “give our congressional authorizing committee the opportunity to develop a legislative solution,” the agency wrote. The paper reveals more about FDA’s latest thinking on LDTs, which has remained under wraps since FDA halted the final LDT guidance 10 days after the November 8 election.
Based on feedback from laboratory professionals groups, diagnostics manufacturers, and others, FDA offers an alternative to its 2014 draft guidance and suggests exempting all LDTs currently on the market from FDA oversight—except for adverse event and malfunction reporting—as well as so-called traditional LDTs and tests for public health surveillance. Based on its analysis of stakeholder feedback, FDA believes that “a prospective oversight framework that focuses on new and significantly modified high- and moderate-risk LDTs would best serve public health and advance laboratory medicine.”
New low-risk and traditional LDTs would not require oversight. However, FDA should “retain its ability to enforce premarket review, quality systems, and other applicable requirements for any LDT,” if the agency discovers that the test is not analytically and clinically valid, the manufacturer of an LDT has engaged in deceptive promotion, or there is a reasonable probability that the LDT will cause death or serious adverse health consequences.
FDA also proposed that its own oversight and that of the Centers for Medicare and Medicaid Services under CLIA should be complementary and not duplicative. Many lab advocacy groups have focused on the issue of duplicative regulation. In an AACC position statement released in February 2016, the association recommended that CLIA remain the primary mechanism of regulating LDTs and that CLIA be updated to require laboratories to demonstrate that LDTs are clinically valid for use in medical decisions.
In the discussion paper, FDA also proposes expanding its third party premarket review program to include certain LDTs that would require oversight and suggests that a phase-in timeline for LDT regulation be simplified from 9 years to 4 years. FDA noted that the paper is meant to further public dialogue and does not represent a formal, enforceable position.