Hardware Podcasts

Examining the HHS Proposal for Premarket Notification Exemptions

Global Medical Device Podcast · 7 Jun 2021 · 37m · Episode 211

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer to critique the HHS proposal to exempt over 80 device types, including exam gloves, thermometers, infusion pumps, and ventilators, from 510(k) requirements. Drues argues that lumping simple PPE with life-sustaining devices like ventilators ignores critical safety distinctions and bypasses necessary FDA consultation. He emphasizes that regulatory science must begin with biology and engineering rather than paperwork, warning that down-classifying complex devices without rigorous review compromises patient safety and competitive integrity.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru
Also
HHS, FDA, 510(k), PMA, De Novo, EUA

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