Hardware Podcasts

Positive and Negative Impacts of EUA on the Medical Device Industry

Global Medical Device Podcast · 12 Nov 2020 · 37m · Episode 167

What this episode covers

Erica Loring, a regulatory expert at Greenlight Guru, discusses the positive and negative impacts of Emergency Use Authorization (EUA) on the medical device industry with host Jon Speer. They analyze how the surge in EUA applications for PPE and IVDs strained FDA resources, leading to slower reviews for non-COVID devices and concerns about reduced review rigor. Loring highlights the risks of companies without established quality management systems (QMS) entering the market and the downstream supply chain disruptions affecting biocompatibility testing and component sourcing.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Greenlight Guru, FDA, Roche, Abbott, BD, Fisher Scientific

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