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Events listed on BioOhio's Events Calendar are subject to change by the Event Organizer. Visit the organizer's website for current details.

Transitioning from EUA to 510(k) Clearance for IVD Products, What to Expect, a NAMSA webinar

July 16 @ 11:00 am - 12:00 pm

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 BioOhio member 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.

Click here to register.

Details

Date:
July 16
Time:
11:00 am - 12:00 pm
Event Categories:
,
Website:
https://www.namsa.com/webinars/transitioning-eua-510k-clearance-for-ivd-products/

Venue

Online Event
OH United States

Organizer

NAMSA
Phone:
(419) 666-9455
Website:
https://www.namsa.com/

BioOhio

Additional Event Details
BioOhio Member Event