The concept of a traceable file collecting all usability outputs — evaluation plan, hazard use scenarios, and evaluation report — in one retrievable location.
AMD1:2020 made no substantive change here — editorial alignment with ISO 14971:2019 and ISO 13485:2016 references only.
Completeness of the file at submission — FDA expects the full iterative record, not just the final summative report.
Maps to
IEC 62366: §4.2 USABILITY ENGINEERING FILE
ISO 13485: §4.2.4 Control of documents
Pre-QMSR Part 820 (legacy QSR): §820.40 Document controls.
Requirement text
The results of the usability engineering process shall be stored in the USABILITY ENGINEERING FILE. The records and other documents that form the file may form part of other documents and files. The file must be a traceable, complete record of the usability work for the device, containing all usability engineering outputs.
Why this clause exists
Without a centralized, traceable usability engineering file, the iterative evidence that demonstrates safe design is invisible to regulators and auditors — even when the individual activities were conducted diligently. FDA human factors reviewers have rejected the majority of 510(k) human factors submissions not because testing was absent, but because the submission contained only the final summative report without the formative evaluation records, use-related risk analysis, and iterative design history that prove the final design emerged from a structured process rather than a one-time test. IEC 62366-1:2015 clause 4.2 formalizes the file requirement because the standard shifted from a focus on the summative testing artifact to a focus on the process that produced the tested design — and a process can only be audited through the records it generates. The traceability obligation is specifically important because it creates the evidentiary path from a hazard-related use scenario, through the UI design change that mitigated it, to the summative test case that confirmed the mitigation was effective — a path that must be reconstructable by an auditor who was not present during development.
What changed
IEC 62366-1:2015 replaced the 2007 first edition with a major restructuring. The standard was split into Part 1 (normative requirements) and Part 2 (IEC TR 62366-2, informative guidance and methods). The scope broadened to include hazards of all types including psychological hazards, not just direct physical hazards.
The standard introduced a formative/summative evaluation framework not present in 2007. The 2007 requirement to identify primary operating functions was removed — instead, the 2015 version mandates identification and evaluation of hazard-related use scenarios.
Amendment 1 (IEC 62366-1:2015+AMD1:2020 CSV) made no substantive normative change to this clause. Changes were editorial: the normative reference to ISO 14971:2007 was updated to ISO 14971:2019 throughout the standard, ISO 13485 reference updated to 2016 edition, and defined-term capitalization conventions were applied consistently.
Common gaps (what we see in audits)
- Usability Engineering File incomplete or missing — Approximately 90% of human factors testing reports submitted to the FDA in 510(k) submissions are deficient because the submission includes only the final summative testing report. FDA expects the full Usability Engineering File including the Use-Related Risk Analysis, formative evaluation records, and the iterative design process that led to the final design.