In 2021, FDA reviewers found major deficiencies in an estimated 80% of PMA submissions and in 67% of 510(k) submissions.
Premarket submission risks are critical, as failures can result in significant business and healthcare consequences. Quality issues often lead to denials, rejections, costly overruns, time-to-market delays, and reputational harm. While the statistics on submission failures are concerning, they only tell part of the story. MedTech OEMs can uncover strategies for mitigating premarket submission risks and avoid these pitfalls. By proactively identifying and addressing these risks, manufacturers can streamline the approval process, minimize setbacks, and improve their chances of success in the market.
Learn more by viewing Identifying & Mitigating Article