Advancing EUA IVD Products Toward Full Marketing Status

This workshop will explore key considerations for using real-world data (RWD) to generate real-world evidence (RWE) to help support in vitro diagnostic (IVD) products available under FDA’s emergency use authorization (EUA) to advance to full marketing status. A roadmap for diagnostic evaluations during emergencies would help enable stakeholders to have templates to use to expedite evaluation of laboratory-based tests and point of care technologies. By convening a broad range of government and industry stakeholders, the goal of the workshop is:

To identify challenges and next steps to the use of RWD/RWE to help support the advancement of EUA IVD products to full marketing status.

The projected outcomes of the workshop include:

  • Identify test case(s) of interest to stakeholders
  • Discussion to inform development of a roadmap for diagnostic evaluations during emergencies, to include what elements to collect (and how)
  • Identify potential projects or next steps for the test case(s) of interest

Keynote Speakers:

  • Luciana Borio, MD; Vice President, Technical Staff | In-Q-Tel
  • Nira Pollock, MD, PhD; Assoc Medical Director of Infectious Diseases Diagnostic Laboratory at Boston Children’s Hospital, faculty member of the Division of Infectious Diseases at Beth Israel Deaconess Medical Center, Boston, MA.

FDA Speakers:

  • RADM Denise Hinton, FDA Chief Scientist
  • Timothy Stenzel, MD, PhD, Director, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH
  • Uwe Scherf, M.Sc., PhD, Director, Division of Microbiology Devices, OHT7: Office of In Vitro Diagnostics and Radiological Health | CDRH