Identifying and Mitigating Premarket Submission Risks

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

These submission failures are a serious problem—the business and healthcare ramifications can be significant. Submission quality issues lead to denials and rejections that oftentimes result in time and cost overruns, time-to-market delays, and reputational harm. The numbers associated with premarket submission failures are interesting and truly alarming but on their own tell only part of the story. Tune in to this edition of The MedAcuity Minute to learn what’s behind these numbers and how MedTech OEMs can avoid joining these statistics.

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