Global Medical Device Podcast Powered By Greenlight.guru

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) review process. It’s called, eSTAR, or electronic Submission Template And Resource. Today’s guest is Mike Drues of Vascular Sciences. Together, we discuss the details of the eSTAR Pilot Program to help you understand what you need to know and do as medical device professionals. Some of the highlights of the show include: - New Format, Same Information: Content and regulatory burden remain unchanged, but the template is in PDF format and eliminates RTA Checklist. - Two-Fold, Two-Step Process: eSTAR aims to increase efficiency of 510(k) administrative and scientific reviews to decrease rejected 510(k) submissions. - FDA is seeking nine companies that represent a broad medical device industry to volunteer at least one 510(k) submission and provide feedback on eSTAR. - Additional Technical Requirements: Medical device must include software and come in contact with body tissue, but not necessarily the body or