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.
Areas Covered in the Webinar:
Who Will Benefit:
Duration: 60 Minutes
Group-Max. 10 Attendees/Location (For Multiple Locations Contact Customer Care)
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dennis Weissman is a nationally known independent analyst and thought leaders in the clinical laboratory and pathology sectors for over three decades. Dennis is president of Dennis Weissman & Associates, LLC of Falls Church, VA, a consultancy which provides market intelligence, M&A advisory services, public policy monitoring & advice and business leadership to diagnostic and life science companies and organizations. He has expertise in Medicare and health care reform policies and trends; clinical lab and pathology payment and compliance policies as well as M&A and business issues and direction to diagnostic and life science companies.
Dennis founded and served as publisher of Washington G-2 Reports (now G2 Intelligence) from 1979 through 1999, an information company that reports on and analyzes the U.S. clinical laboratory industry via newsletters, research reports; webinars and live conferences. Prior to G2, he served as Director of the Washington Office of the American Society for Medical Technology (now ASCLS) and before that, Special Assistant to the Deputy Assistance Secretary for Health, U.S. Department of Health, Education & Welfare (now HHS).