Most medical device companies use a Use Failure Modes and Effects Analysis (uFMEA) to document their use-related risk analysis for a usability engineering file. Unfortunately, the FDA does not want a uFMEA for 510(k) submissions. Instead, the FDA requires that you submit a URRA or risk traceability matrix with only specific information--nothing more and nothing less. They also want the format exactly according to their draft guidance from December 2022. In our November 8th live-streaming video, we will explain the process for creating a uFMEA in the first place. Then we will show you how to quickly convert your uFMEA to a URRA for your FDA 510(k) submission. If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: https://streamyard.com/pal/d/4790150438977536