Hardware Podcasts

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

Global Medical Device Podcast · 15 Dec 2022 · 43m · Episode 294

What this episode covers

Mike Drues, President of Vascular Sciences, discusses the evolution of Emergency Use Authorizations (EUAs) from the COVID-19 pandemic to the emerging Monkeypox health emergency. He highlights that 80% of EUA submissions during the pandemic required revisions due to poor quality and lack of experience among first-time applicants. Drues warns that companies without prior regulatory experience should seek expert help rather than expecting the FDA to guide them through the process.

Most relevant to

established companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru, FDA, HHS, CDC
Also
510 K, De Novo, PMA

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