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Validity : 14th Apr'24 to 24th Apr'24
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. Among key elements of LDT regulation to be discussed include:
The increasing complexity, availability and growing use of LDTs to diagnose common but serious medical conditions such as cancer and heart disease, has sparked FDA’s renewed scrutiny and related policy positions on LDTs which have drawn the attention of Congress and raised serious concerns inside the lab industry. 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.