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Transitioning from EUA to 510(k) for IVD Products: Planning to Execution



April 21, 2022

Access On-Demand Webinar Here.

In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes.

NAMSA invites you to view this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval.

Attendees can expect to learn about:

  • FDA draft guidance expectations
  • Updates from our prior webinar
    • Initial steps to plan for a 510(k) compliance (such as QMS requirements)
    • Planning from timeline perspective
    • Clinical study design requirements for EUA to 510(k)
    • Predicate allotment for COVID-19 tests (serology, nucleic acid)
    • Post-market study requirements for EUA products
    • Scenarios for foreign manufacturers applying for EUAs
  • What Sponsors can do today to prepare regardless of draft guidance (i.e. general good practice)
  • Gap assessment tools
  • Clinical study considerations

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Sonia M. Lecce

Principal Regulatory Consultant, IVD

Sonia Lecce has over 20 years’ experience in the IVD and medical device industry, with over 15 years spent in the area of IVD regulatory affairs. Her experience includes working for Abbott Molecular and Baxter with a focus on IVDs. Additionally, Sonia has experience with molecular products, companion diagnostics, hematology, flow-cytometry, LDTs, ASRs, FISH technology and PCR technology for both oncology and infectious disease. In the area of medical devices, she has worked in medication delivery, pumps and collection devices. She is currently heavily involved in Biologics License Applications for several products for both US (CBER) and Health Canada.

Duan Threats

Senior Regulatory Consultant, IVD

Duan has been in the Medtech industry for 19 years, with a primary focus on In Vitro Diagnostics (IVDs). He has vast experience supporting the regulatory compliance and labelling needs of IVDs—such as, molecular diagnostics (MDx), companion Dx (CDx), hematology analyzers, urinalysis, flow cytometry and hemostasis—in European, U.S. and other global market. Duan has been with NAMSA since 2020 and has previous work experience at Sysmex, Abbott Molecular and MABIS DMI Healthcare.