IDENTIFYING AND MITIGATING PREMARKET SUBMISSION RISKS

Comprehensive Strategies for Identifying, Mitigating, and Managing Premarket Submission Risks in MedTech

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

The statistics surrounding premarket submission failures are both intriguing and concerning, but they only paint part of the picture. To provide a more complete understanding, we compared these figures against the real-world experiences within our client portfolio, relationships, and our own extensive work with medical device Original Equipment Manufacturers (OEMs). This approach allowed us to uncover the story behind the numbers and gain deeper insights into how risks can be mitigated, not just for initial submissions but also for re-submissions if necessary.

In this article, we’ll explore the dynamic and ever-evolving regulatory landscape that medical device manufacturers must navigate. We will offer practical insights on how to align with these shifting regulations and adopt strategies that can drive successful premarket submissions, ensuring products meet all the necessary requirements and reach the market with minimal delays or setbacks.

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