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 track 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 webinar 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.