Where FDA Is Heading in Regulating Laboratory-Developed Tests

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.

Why Should You Attend:

With advances in technology and growing demand for personalized treatment plans, increasing numbers of laboratories are developing and using custom diagnostic tests to keep pace with the changing face of disease as well as to best serve both patients and clinicians alike. Though LDTs have long been subject to the regulatory requirements under the Clinical Laboratory Improvement Amendments (CLIA) FDA’s growing involvement with LDTs leaves affected labs with trying to understand how they would be affected by the prospect for additional federal oversight. Meantime, an April discussion draft for new congressional legislation, the Diagnostics Accuracy and Innovation Act (DAIA) which would affect the regulatory framework of both LDTs and in vitro diagnostic (IVD) test kits adds yet another piece to the complex federal jigsaw puzzle for regulating LDTs.

This webinar details the history of federal regulation of laboratory-developed tests including requirements under CLIA and FDA’s interpretation of its authority under the Food Drug & Cosmetic Act (FDCA). Key policy pronouncements by the FDA for overseeing LDTs will be detailed including: the agency’s stance on a subset of LDTs known as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs); FDA’s plan for a comprehensive framework for LDT oversight; its release of draft documents describing the agency’s proposed regulatory framework for LDTs and subsequent withdrawal, and FDA’s “discussion paper” which outlines a substantially revised “possible approach” to the oversight of LDTs. Possible new federal legislation now being discussed that would affect LDT regulation will also be covered along with the current outlook for further action by the Trump Administration and/or Congress affecting LDT oversight.