eSTAR Submissions, a New Method for US FDA Medical Device Submissions
-
eSTAR Submissions, a New Method for US FDA Medical Device Submissions
Identifying and Overcoming eSTAR Challenges for a Successful Submission As of October 1, 2023, all 510(k) submissions must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive…
-
Stay Purpose-Focused (and Know the Details are in Check)
You have vision. That’s why you are part of the medical device community. But to take your innovative ideas to fruition, there are countless regulatory hoops that must be successfully jumped through. To keep your efforts on point, you need a project and process management system that ensures operational efficiency, and control. Robust tools will…