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Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect



July 16, 2020

Access this On-Demand Webinar here.

In Vitro Diagnostic (IVD) products go through a stringent 510(k) evaluation process in order to be certified and placed in the U.S. However, as a result of the ongoing COVID-19 Pandemic, several assays and analyzers have entered the market through the Emergency Use Authorization (EUA) pathway to fast tracked approval. While EUA provides an opportunity for IVD manufacturers, these IVDs will eventually have to comply with U.S. FDA 510(k) requirements to remain on the market.

Join NAMSA for this upcoming panel discussion to learn about the necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval.

Webinar participants will leave with a better understanding of:

  • Initial steps to plan for 510(k) compliance (such as QMS requirements)
  • Planning from a 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

Time will also be allotted for Q&A.

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Jennifer Tibodeau Jensen

Principal Project Manager – IVD

Jennifer Tibodeau Jensen has over 13 years’ experience in the IVD industry. Currently, she serves NAMSA’s IVD Project Manager in which she oversees project cadence in line with pre-determined milestones, forecasting budgets and resource management. Prior to NAMSA, Jen worked at Beckman Coulter for more than a decade, serving in various roles including Senior Project Manager, Manager and Senior and Staff Development Scientist in the Immunoassay Business Unit. She has lead several Troponin I Immunoassay development efforts, including full R&D cycle through verification and validation leading to U.S. FDA clearance. Her experience also includes working for the prestigious Mayo Clinic’s Oncology Department as a Postdoctoral Fellow.

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.