Sections of the Human Factors Engineering Report
| Section | Title | Contents |
|---|---|---|
| 1 | Intended Device Users, Uses, Use Environments, and Training | User profiles, capability differences, use scenarios, use environments, description of training scenarios |
| 2 | Device User Interface | Graphical depiction of device user interface operation sequence flow, task analysis, Labeling |
| 3 | Summary of Known Use Problems | History of problems with similar/previous device Summary of device changes to control these risks |
| 4 | User Task Selection, Characterization, and Prioritization | Risk analysis methods, use-related hazards, safety claims, priority-based on severity of use error consequences |
| 5 | Summary of Formative Evaluations | Summary of previously conducted evaluations of the device user interface and labeling/Instructions for use, expert reviews and usability tests |
| 6 | Validation Testing | Report of final validation test focusing on post-test analysis of any failures or performance difficulties using the labeling (IFU) and user interface |
| 7 | Conclusion | Arguments as to how device use safety is substantiated by the validation test and other HF data |