eSTAR Available for Certain PMS Submissions

On December 6, the U.S. Food and Drug Administration (FDA) announced that eSTAR is now available for voluntary use for certain PMA Submissions. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review.

The updated eSTAR Template includes a guide that follows the recommendations noted in the final guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.