Ask the Expert: Benefits and Challenges of the eStar Submission Process

Ask the Expert: Benefits and Challenges of the eStar Submission Process     As of October 1, 2023, all U.S. FDA 510(k) submissions, unless exempted, must be submitted as electronic submissions using the eSTAR platform. In this column, Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation …

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