Hardware Podcasts

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Global Medical Device Podcast · 12 Jan 2022 · 41m · Episode 242

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to discuss the transition plans for medical devices currently on the market under Emergency Use Authorization (EUA). They explain that EUAs are temporary authorizations with lower regulatory and quality burdens than traditional pathways like 510(k) or De Novo, and warn that companies relying solely on EUA data will likely fail to meet the higher standards required for permanent clearance. Drues advises firms to proactively conduct gap analyses and engage in pre-submissions rather than waiting for FDA termination notices, emphasizing that EUA products must be integrated into a broader long-term regulatory strategy.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, FDA
Also
510(k), De Novo, PMA

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