Join us for a timely discussion on the evolving regulatory landscape surrounding Laboratory Developed Tests (LDTs), hosted in partnership with the RAPS Colorado chapter.
LDTs are in vitro diagnostics designed, manufactured, and used within a single laboratory. Historically, the U.S. FDA exercised enforcement discretion over LDTs, exempting them from the same premarket review as other medical devices. A recent successful court case challenged this approach, arguing that LDTs should be treated as professional services subject to regulation.
Key Topics:
– Where the matter currently stands in the U.S. regulatory environment.
– How companies are adapting their approach to LDT development.
– How international markets are addressing this category of diagnostics.
– Potential shifts in FDA oversight and implications for the future.
Life Sciences - In Focus
Laboratory Developed Tests: What Now, Where Next?
May 21, 4 pm (GMT+1) | 5 pm (CEST) | 11 am (EDT) - Register now!
Panelists
Cortez McBerry
Regulatory Consulting Director (Medical Devices) & Partner at NDA Partners
Sean McCarthy
Senior Regulatory Manager at Enhanced Compliance, Inc. (ECI)
Tristin Wolff Cope
Director of Regulatory Compliance at Biodesix
Host
Karen M. Tkaczyk
Director of Sales – Life Sciences, Vistatec
Karen (MChem, Chemistry with French, University of Manchester; PhD, Chemistry, University of Cambridge) began her career as a development chemist, then for many years was a freelance translator, editor, and trainer on scientific writing and editing. At Vistatec, she leads sales for the Life Sciences division.