What problem does it solve? Medical device manufacturers struggle to determine which FDA Human Factors Engineering (HFE) submission category applies to their device and what documentation is required, risking technical screening holds or unnecessary summative validation testing costs. ## Core Features & Use Cases - Submission Category Classification: Applies the four-step Decision Points A-D framework from the FDA 2026 final guidance to classify submissions as Category 1, 2, or 3. - URRA Analysis Framework: Generates use-related risk analysis templates with critical task identification aligned to ISO 14971 risk matrices. - Validation Test Plan Generation: Produces summative human factors testing protocols covering user counts, environments, task scripts, and statistical acceptance criteria. - Use Case: A manufacturer modifying a device label can input the device description to determine whether the change triggers Category 2 documentation or can use Decision Point D to justify avoiding summative validation testing. ## Quick Start Describe your medical device and its user interface changes, then ask the skill to determine the FDA HFE submission category and generate the required documentation checklist.
