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NAMSA invites you to view this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to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- FDA draft guidance expectations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- What Sponsors can do today to prepare regardless of draft guidance (i.e. general good practice)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