# Human Factors (or Usability Engineering) | Botable Glossary

https://www.botable.ai/glossary/human-factors-or-usability-engineering

> Company-published glossary entry: useful as an introductory, company-curated summary of HF/UE and how it relates to FDA design controls. Good for high-level explanation and practical pointers, but not a substitute for primary FDA guidance or regulatory documentation; attribute claims to Botable and link to original sources for regulatory decisions.

## Summary

Human Factors (or Usability Engineering) is defined as the study of interactions between humans and a device/interface and the design of the device‑human interface. The page explains that HF/UE is a mandatory element of FDA Design Controls and risk management for medical devices and provides FAQs on when usability testing is required, what testing must demonstrate, examples of device classes with HF requirements, and how HF findings feed into training and labeling risk mitigations.

## Audience

Medical device manufacturers and regulatory/quality professionals

## Prompts this page answers

- What is human factors (usability engineering) in the context of medical devices?
- When is usability testing required for FDA-regulated medical devices?
- What must human factors testing demonstrate for a medical device?
- Which medical device categories commonly require human factors validation testing?
- How do human factors findings affect training and labeling risk mitigation?

## Purpose

To define Human Factors/Usability Engineering and explain its role and regulatory relevance for medical device design controls and risk management.

## Highlights

- Human Factors are defined as the study of interactions between humans and the device (interface) and the design of the device-human interface.
- HF/UE are mandatory components of Design Controls and risk management for FDA-regulated medical devices.
- Usability testing is often required as a special control (commonly for Class II devices) and is part of Design Validation.
- Usability testing must typically show intended users can safely and correctly use the device, sometimes based solely on reading the instructions for use.
- Certain device categories (e.g., interventional imaging systems, surgical systems, gastrointestinal devices, whole slide imaging systems, OTC genetic health risk devices) have specific HF testing requirements.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/human-factors-or-usability-engineering.

## Publisher



## Topics

- human factors
- usability engineering
- FDA design controls
- usability testing
- human factors validation

## Key entities

- **FDA** (organization): U.S. Food and Drug Administration, referenced in the page regarding guidance and regulatory expectations.
- **Design Controls** (other): Design Controls referenced as a requirement that includes Human Factors. — /glossary/design-controls
- **21 CFR 820** (other): Regulatory citation referenced in the context of design controls and risk management. — /glossary/21-cfr-part-820
- **Genetic Health Risk (GHR) Assessment Devices (OTC)** (other): Device category with explicit user comprehension study requirements described on the page.
- **Aesthetic OTC Devices** (other): Device category requiring label comprehension and self-selection performance evaluations.
- **Interventional Imaging Systems** (other): Example device class listed as requiring HF evaluation of UI and labeling.
- **Surgical Systems** (other): Example device class listed as requiring HF validation testing for safe use in an operating room environment.
- **Gastrointestinal Devices** (other): Example device class listed as requiring HF testing to demonstrate safe and correct use.
- **Whole Slide Imaging Systems** (other): Example device class listed as requiring a detailed human factor engineering process.

## Metadata

- Type: article