Advancing EUA IVD Products Toward Full Marketing Status

The Medical Device Innovation Consortium (MDIC) will host a workshop on 3 Feb 2020 to explore key considerations for using real world data 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