MDIC-FDA Workshop: Advancing EUA IVD Products Toward Full Marketing Status
On February 3, 2020, MDIC and FDA held a workshop at the FDA White Oak Campus in White Oak, Maryland, focusing on advancing emergency use authorization (EUA) for in vitro diagnostic (IVD) products toward full marketing status. The event gathered 240 participants, including FDA representatives, IVD sponsors, researchers, and organizations involved in the development and study of IVDs.
During the workshop, participants examined key considerations for utilizing real-world data (RWD) to generate real-world evidence (RWE) that could support IVD products in transitioning from EUA to full marketing status (either De Novo or 510(k)). They identified several challenges, such as limited sample availability and difficulties in accessing RWD. Additionally, the discussions outlined next steps for leveraging RWD and RWE to assist more EUA IVD products in obtaining full marketing approval.
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
Morning Sessions 1
The workshop explored the role of Emergency Use Authorizations (EUAs) in outbreak response, emphasizing the challenges of transitioning diagnostic tests from emergency authorization to full FDA approval. Keynote speakers highlighted lessons from past outbreaks, such as Ebola and COVID-19, stressing the need for collaboration, regulatory clarity, and real-world data (RWD) to support diagnostics. FDA representatives discussed the agency’s role in expediting diagnostic test availability and the importance of RWE in regulatory decision-making. They also addressed barriers to EUA products achieving full market status and potential solutions, including leveraging high-quality healthcare data and establishing international frameworks for emergency diagnostics.
Morning Sessions 2
This session explored industry perspectives on the challenges and opportunities of transitioning diagnostics from Emergency Use Authorization (EUA) to full FDA approval. A case study from InBios detailed how proactive engagement with the FDA and collaboration with organizations like the CDC and BARDA helped secure De Novo marketing clearance for a Zika test. An industry panel discussed key barriers, including limited data availability, high costs, and commercial sustainability concerns. Potential solutions included establishing a standardized sample bank, maintaining a national stockpile of IVDs, and leveraging real-world data (RWD) to support regulatory approval.
Afternoon Sessions 1
This session focused on data management, real-world evidence (RWE), and public-private partnerships in advancing diagnostics from Emergency Use Authorization (EUA) to full approval. Presenters discussed efforts to standardize data collection during outbreaks, such as the Ebola response in the Democratic Republic of the Congo, and the need for reliable, regulatory-grade data to support decision-making. Initiatives like SHIELDx aim to harmonize diagnostic data standards, while BARDA provides funding and regulatory support to accelerate EUA transitions. A panel discussion emphasized that transitioning EUAs to full market status is rarely profitable, underscoring the need for collaboration and sustainable resources to support these efforts.
Slides for Part 1
Slides for Part 2
Slides for Part 3
Slides for Part 4
Biorepositories and Reference Materials
This session focused on the role of biorepositories, reference materials, and regulatory frameworks in supporting diagnostic development during public health emergencies. Experts discussed the importance of standardized assay controls, challenges in providing reference materials during outbreaks, and the differences between the WHO’s Emergency Use Assessment Listing (EUAL) and the FDA’s EUA process. A panel addressed barriers to transitioning EUA diagnostics to full approval, emphasizing the need for common data standards, improved specimen availability, and financial incentives for manufacturers. Collaboration between government agencies, regulators, and industry stakeholders was highlighted as key to improving emergency response and accelerating market authorization.