Medical Innovation Exchange

eStar

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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FDA Issues Three New Draft Guidances on the 510(k) Program

FDA Issues Three New Draft Guidances on the 510(k) Program     On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices while continuing to bring critical devices to patients. The new guidances include: On October …

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