11:30 am PLENARY KEYNOTE PRESENTATION: Talk Title to be Announced
Courtney H. LiasCourtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices, United States Food and Drug Administration (FDA)

12:00 pm Plenary Fireside Chat Introduction (Sponsorship Opportunity Available)

12:10 pm PLENARY FIRESIDE CHAT: Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward
B. Melina CimlerB. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC
Laboratory-developed tests (LDTs) are an important part of healthcare. The FDA released a proposed rule on September 29, 2023, that seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal FD&C Act, including when the manufacturer of the IVD is a laboratory. FDA is proposing a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach to LDTs.  

This panel brings together stakeholders to: 

  • Discuss elements of the proposed rule including classification of IVDs 
  • Impact on various stakeholders and expected activities  
  • CMS vs. FDA roles as to oversight of laboratory tests  
  • Regulation of LDTs under the IVDR

Stefan BurdeStefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc.
Laurie MenserLaurie Menser, CEO, Association for Molecular Pathology
Girish PutchaGirish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics