Hardware Podcasts

#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

Global Medical Device Podcast · 19 Dec 2024 · 50m · Episode 396

What this episode covers

Regulatory consultant Mike Drues, president of Vascular Sciences, explains why device descriptions are the most poorly written part of FDA submissions and how they determine classification, testing, and approval pathways. He advises manufacturers to write layered descriptions—simple overviews for general audiences and detailed appendices for specialists—and to test efficacy by having unfamiliar readers explain the device back to them. Drues recommends using videos to demonstrate device function during pre-submission meetings to avoid real-time failures and suggests starting with simple objects like a garden hose to refine the writing process.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 510k, PMA, De Novo

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