PLENARY SESSION

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 PANEL: Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward
PANEL MODERATOR: B. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC
B. Melina CimlerLaboratory-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

PANELISTS:
Stefan BurdeStefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc.


Girish PutchaGirish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics


Lakshman Ramamurthy, PhDLakshman Ramamurthy, PhD, Vice President Regulatory Affairs, GRAIL 

Anna ScrimentiAnna Scrimenti, Associate Director, Public Policy & Advocacy, Association for Molecular Pathology