Hardware Podcasts

A Regulatory Gap Analysis of FDA's Systems & Policies

Global Medical Device Podcast · 26 Jan 2022 · 53m · Episode 244

What this episode covers

Mike Drues of Vascular Sciences joins host Jon Speer of Greenlight Guru to conduct a gap analysis of the FDA's regulatory framework, arguing that the system is too reactive. Drues identifies 'predicate creep' in the 510(k) process and 'change creep' via letters-to-file as major inefficiencies, proposing a 'ketchup 510(k)' to aggregate minor changes. He also advocates for a formal mechanism to designate wellness devices, a '510(k)-like PMA' for incremental Class 3 innovations, and a dedicated pathway for personalized medicine, such as 3D printed devices.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 510(k), CAPA, Custom Device Exemption, Breakthrough Devices Program, Safer Technologies Program

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