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Introduction
What's in the Guidance
Human Factors Decision Tree
Table 1 Contents for Human Factors Risk Categories 1, 2, and 3
Table 2 Use-Related Risk Analysis in Tabular Format
Table 3 Comparative URRA with Submitter's Comments
Recommended Usability Content for 510k pre-market submission
Examples of each Risk Category
Searching Adverse Event Databases and Identifying Use Errors
510k Training
Nyquil Chicken - Abnormal Use Case Study
Comments on the Ugly Christmas Sweater
Coming Soon - 510(k) Course Calendar for 2023