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Premarket Submission Risks

In 2021, FDA reviewers found major deficiencies in an estimated 80% of PMA submissions and in 67% of 510(k) submissions.1

The numbers associated with premarket submission failures are interesting and truly alarming, but on their own tell only part of the story. To offer additional real-world context, we compared this data against our client portfolio, relationships, and our own experiences working with device OEMs. We did this to get to the story behind the numbers and to offer insights on mitigating risks for both “pre-“, and potentially, “re-“ submissions.

In this article, we’ll take a closer look at the ever-changing regulatory landscape and offer insights into how medical device manufacturers can learn to align and evolve to ensure successful premarket submissions.

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  1. 3rd Quarter FY 2022 MDUFA IV Performance Report – September 7, 2022