Boston Chapter Virtual Event: Shining Light on eSTAR Submissions – An FDA Reviewer and Industry Disc

This webinar will provide an overview of the use of eSTAR and provide both an industry and FDA reviewer perspective on the process and tips to make your eSTAR submission successful. eSTAR is free PDF submission tool that is required for all medical device 510(k) submissions. eSTAR is voluntary for medical device De Novo submissions (until Oct 1 2025) , 513(g) requests, PMA and Pre-Submissions to CDRH. 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.

Topics will include:

• How to prepare a submission using eSTAR
• How to submit an eSTAR
• Does the RTA process still apply?
• What types of files can be added?
• How to submit Additional Information with eSTAR.
• FDA and industry tips for successful submission.
• Q&A