FDA Updates eSTAR Program: Human Factors Content Added and Expanded PreSTAR Functionality
The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.
FDA Finalizes Risk-Based Guidance on Human Factors Information in Medical Device Submissions
The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.