Hardware Podcasts

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Global Medical Device Podcast · 8 Apr 2020 · 45m · Episode 140

What this episode covers

Mike Drues of Vascular Sciences explains the regulatory framework for Emergency Use Authorization (EUA) to host Jon Speer of Greenlight Guru, emphasizing that it is a temporary pathway, not a shortcut for reduced testing. Drues details the specific criteria for EUAs, including the requirement to diagnose, treat, or prevent serious conditions when no adequate alternatives exist, and warns against the dangers of political pressure leading to ineffective devices like the 170 non-functional ventilators delivered in Los Angeles. He advises companies to prioritize safety and efficacy testing by triaging requirements based on risk, rather than treating the EUA as a way to bypass rigorous engineering standards.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences
Also
FDA, SARS, COVID-19, IEC 60601, 510(k), PMA

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