FDA Issues Guidance on Applying Human Factors and Usability Engineering to Medical Devices
FDA has issued guidance on applying human factors and usability engineering to medical devices, focusing on user interface design, use-related risk management, critical tasks and human factors validation testing.
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.