Hardware Podcasts

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Global Medical Device Podcast · 29 Jan 2020 · 37m · Episode 131

What this episode covers

Mike Drues, a subject matter expert from Vascular Sciences, joins host John Speer of Greenlight Guru to analyze the FDA CDRH's 2020 regulatory science priorities. Drues highlights that while eight priorities remain consistent with previous years, critical areas like reprocessing reusable devices and human factors/usability have been dropped, likely due to a lack of recent high-profile press coverage rather than resolved industry issues. The discussion emphasizes that the report is largely non-actionable and urges the medical device industry to develop its own prioritized lists to foster proactive, substantive dialogue with the FDA rather than waiting for reactive regulatory guidance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
FDA, Vascular Sciences, Greenlight Guru
Also
CDRH, UCLA, ISO, EU MDR, PMA

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