Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff¶
U.S. Food and Drug Administration. (2016). Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff: Guidance for Industry and Food and Drug Administration Staff. U.S. Food and Drug Administration.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Domain-specific¶
- Microcopy Ambiguity
- Web and mobile form design — "Submit" versus "Save draft" versus "Publish," "Cancel" versus "Back," and address-field labels read more narrowly than intended. Medical-device interfaces — ambiguous unit labels (mg/mcg/mL), mode indicators, and alarm-silence labels, recurring root-cause findings in adverse-event analyses
This sourceFDA guidance recommending human factors and usability engineering in device design so as to minimize use errors and the resulting harm.
Supported in partVerified against a saved copy of the source
“This guidance document provides the FDA’s recommendations to assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective”
- Web and mobile form design — "Submit" versus "Save draft" versus "Publish," "Cancel" versus "Back," and address-field labels read more narrowly than intended. Medical-device interfaces — ambiguous unit labels (mg/mcg/mL), mode indicators, and alarm-silence labels, recurring root-cause findings in adverse-event analyses
- Touch-Target Miss
- Mobile and web UI — the home turf, where the design guidance (Apple HIG and Material 44×44-point targets with 8-point spacing, WCAG 2.5.8's 24 CSS pixels) is codified. Accessibility engineering — designing for the low-precision tail of the operator population (tremor, motor impairment, gloves, motion), where the geometric scan is the audit method. Public kiosks and voting machines — high-stakes single-session interfaces where a geometry-guaranteed miss rate excludes or misdirects users. Medical-device interfaces — infusion pumps and bedside medication systems under FDA human-factors guidance, where adjacent-control activation can cause harm
This sourceFDA guidance on applying human factors and usability engineering to medical devices so that use errors and resulting harm are minimised for the intended users and use environments.
Supported in partVerified against a saved copy of the source
“maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments”
- Mobile and web UI — the home turf, where the design guidance (Apple HIG and Material 44×44-point targets with 8-point spacing, WCAG 2.5.8's 24 CSS pixels) is codified. Accessibility engineering — designing for the low-precision tail of the operator population (tremor, motor impairment, gloves, motion), where the geometric scan is the audit method. Public kiosks and voting machines — high-stakes single-session interfaces where a geometry-guaranteed miss rate excludes or misdirects users. Medical-device interfaces — infusion pumps and bedside medication systems under FDA human-factors guidance, where adjacent-control activation can cause harm
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Read against the text for 2 of 2 citations: 2 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
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