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2020 RAPS Regulatory Convergence Main banner

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Medical Devices (includes IVDs)

FDA Emergency Use Authorization (EUA) program in response to COVID-19

Tuesday, September 15, 2020

11:00 AM – 12:30 PM EDT

Moderator(s)

Mac McKeen, RAC, FRAPS, MBA, RAC FRAPS MBA

Fellow, Regulatory Science
Boston Scientific - ENTERPRISE

Speaker(s)

AK

Angela Krueger

US Food and Drug Adminstration

Slides
Annabel Tsai, PhD

Sr. manager, RA/QA
InBios

Slides

The Emergency Use Authorization (EUA) regulatory pathway is being used by the FDA to address the immediate public health emergency during the COVID-19 Pandemic.

What is an EUA?

In this session we will hear directly from FDA on the current status of the EUA program and how to efficiently navigate the EUA process. In addition, the session will present an industry example of how to handle design changes after EUA is granted, some of the barriers to converting from EUA to direct de novo or 510(k) clearance, and how to plan an efficient regulatory strategy towards IVD marketing clearance. This presentation includes lessons learned by one company that successfully navigated these processes.

Learning Objectives:

Describe the differences in EUA requirements vs. IVD clearance requirements.
Plan how to leverage EUA studies towards direct de novo or 510(k) clearance.