Where FDA Is Heading in Regulating Laboratory-Developed Tests

Dennis Weissman

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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:

  • Regulatory requirements under CLIA
  • FDA’s interpretation of its authority to regulate lab tests under the Food Drug & Cosmetic Act
  • FDA’s reasoning for applying enforcement discretion to LDTs
  • The agency’s plan and subsequent proposed guidance to regulate a newly defined subset of LDTs, In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
  • FDA’s position for issuing warning letters to labs regarding marketing of specific tests
  • FDA approach under its proposed regulatory framework for LDTs
  • Industry’s reasoning for opposing FDA oversight of LDTs
  • Rationale for the agency’s decision to withdraw its proposed regulatory guidance of LDTs
  • FDA latest thinking on “possible approach” to regulating LDTs
  • How possible new federal legislation would impact LDT oversight
  • Outlook for further regulation of LDTs by FDA and/or Congress

Who Will Benefit:

  • Clinical pathologists
  • Senior laboratory executives in academic, research, hospital and independent labs including CEOs, COOs, CFOs
  • Medical directors
  • Administrative directors & senior managers
  • Directors of reimbursement, billing & finance
  • Head of legal and compliance office
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Speaker: Dennis Weissman, President, Dennis Weissman and Associates LLC

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).

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