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


Manage episode 287393264 series 1017311
By Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, and Consultants; R. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

Premarket Approval (PMA) is a FDA regulatory pathway designated for Class III medical devices that has historically been known to evoke a fearful, negative response by medical device professionals.

In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, known in the industry as Mr. Regulatory, about the reasons why the PMA process is so dreaded by manufacturers bringing a Class III medical device to market in the United States.

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