FDA Human Factors — Process vs Submission Content
Reguverse separates two complementary FDA guidance documents. Do not conflate them with the IEC 62366-1 Usability Engineering File (UEF) process backbone used in the product harness.
1. Process guidance
Title: Applying Human Factors and Usability Engineering to Medical Devices
Role: How to perform HFE/UE as part of risk management and design controls (users, environments, UI, formative work, HF validation testing methods).
UEF mapping (typical): Use Specification ↔ users/use environments; critical tasks ↔ hazard-related use scenarios selected for summative; formative ↔ Clause 5.8; HF validation ↔ summative Clause 5.9.
2. Content / marketing-submission guidance (2026)
Title: Content of Human Factors Information in Medical Device Marketing Submissions
Published: 29 May 2026 (Federal Register announcement)
Implementation expectation: submissions received on or after 1 August 2026
Applies to: 510(k), De Novo, PMA, HDE (CDRH medical devices)
Does not replace: risk management / design controls / performing HFE activities — it tells sponsors what level of HF documentation to file.
Town hall: CDRH 22 July 2026 (slides/transcript via CDRH Learn).
HF Submission Categories
| Category | When (high level) | What to provide |
|---|---|---|
| 1 | Modified device; no change to UI / users / uses / environments / training / labeling | Conclusion + high-level HF summary |
| 2 | No critical tasks (new) / no new or impacted critical tasks (modified), or Decision Point D concludes validation data need not be submitted | Cat1 content + users/UI/known-use-problems + rationale |
| 3 | Critical tasks warrant filing HF validation | Full HFE/UE report incl. preliminary analyses, URRA, critical tasks, HF validation of final design |
Flowchart decisions: A modification? → B UI/users/uses/env/training/labeling change? → C critical tasks? → D submit HF validation data?
Decision Point D is central: critical tasks do not automatically force Category 3 filing.
URRA
Use-Related Risk Analysis (guidance Table 2) and comparative URRA (Table 3) are living analyses. Typical columns: task, use error, hazardous situation, harm, severity, critical task Y/N, risk controls, validation method for control effectiveness.
eSTAR
Updated eSTAR templates prompt Category selection (“Guide Me” or sponsor-chosen) and locate supporting sections.
3. How Reguverse implements this
| Layer | Implementation |
|---|---|
| Process UEF | Built-in Usability Harness (#231) — IEC 62366-1 Document+Study |
| UE ↔ RM | #233–#235 (same hazard table, Sync) |
| FDA submission overlay | #236 Path B — Category wizard + derived URRA view + Submission Pack |
| FDA pack substantive generation | #237 Phase 3 — hybrid assembly: code-injects Use Spec / UI Spec / URRA / Formative·Summative Study excerpts; LLM fills narrative slots only; Word download prefers persisted pack_markdown |
| Feature Visibility | Continues under evidence_registry (no new feature key) |
| Scope (current) | MD only; combination products excluded; IVD eSTAR deferred |
Summative hard gate (process): EU/IVDR/NMPA projects still require selected HRUS + substantive UI Spec before creating Summative Studies (#233 D10).
Submission pack (FDA Cat 1/2): may omit HF validation details even if process Summative Studies exist — UI states this explicitly.
Generate rule: never invent participant counts / pass rates; missing UEF evidence becomes [TO BE COMPLETED].