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The End is Near: Convert your FDA Emergency Use Authorization to a Medical Device Clearance with Eyes Wide Open

Virtual Event

April 27, 2021 @ 12:00 PM 1:00 PM

Join our webinar to learn about the FDA’s use and evolution of its EUA regulatory pathway during the pandemic and best practices to transition your medical device from an EUA to an FDA cleared medical device to remain on the market in a post-pandemic world.

Jim Sergi
President @CSSi LifeSciences
Jim Sergi is the Founder and the President of CSSi LifeSciences, a global drug discovery and technology development company providing fully integrated, specialized regulatory and clinical services for pharmaceutical and medical device companies. Prior to this role, Jim was the founder and managing partner of Bay Tower Capital, a life sciences merchant bank and the founder and CEO of ProED Communications, a healthcare services and drug development company. He has been responsible for over 85 successful NDA/BLA approvals and over 250 medical device approvals. Jim serves a scientific reviewer for the NIH SBIR/STTR Commercial Readiness Program, as well as a mentor to the NIH/NHLBI and the NIH Larta FeedForward programs.
Michael Gaba
Vice Chair, FDA Practice Group @Polsinelli PC
Michael Gaba provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible.


April 27
12:00 PM – 1:00 PM


CSSi LifeSciences
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