Hardware Podcasts

Demystifying the De Novo Process

Global Medical Device Podcast · 12 May 2022 · 37m · Episode 260

What this episode covers

Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, explains the De Novo pathway for novel medical devices that lack a substantial equivalent predicate. He contrasts this with 510(k) and PMA submissions, highlighting that De Novo allows innovators to set regulatory standards and special controls for future competitors. MacCuspie advises companies to use pre-submission meetings to align with the FDA, avoid analysis paralysis by launching version 1 products, and focus on patient benefit rather than just compliance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Proxima CRO
Also
FDA, Green Light Guru, 510(k), PMA, CE mark

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