Tag Archives: 510(k) submissions

Dhirti Roy

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

Dhirti Roy

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

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