Hardware Podcasts

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Global Medical Device Podcast · 25 Mar 2021 · 46m · Episode 187

What this episode covers

David Pudwill, known as Mr. Regulatory, explains why the FDA's Premarket Approval (PMA) pathway for Class III medical devices is feared by manufacturers due to its high cost, long timelines, and uncertainty. He contrasts the PMA process with 510(k) and De Novo pathways, highlighting that PMAs require substantial clinical data and carry significant user fees, such as $366,000 for original submissions. Pudwill advises companies to consider strategic alternatives, such as using lower-risk classifications for initial revenue generation or leveraging the Pre-Submission program to engage with the FDA early in development.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Green Light Guru
Also
FDA, CMS, Mr. Regulatory

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