Human Factors Engineering & FDA Guidance

Ke Li Yew
Ke Li Yew

Human Factors Engineering & Usability Engineering as Risk Management

In February 2016, the U.S. Food and Drug Administration (FDA) issued nonbinding recommendations addressing the use of human factors engineering in medical device product development. The FDA identified both human factors engineering (HFE) and usability engineering (UE) as key risk-mitigating tools for medical device manufacturers.

Mitigating human error and reducing risk is the central motivation behind the FDA’s recommendations. The use of robust design and usability engineering processes when building medical devices, according to the FDA, may have future implications for both market approval and future liability.

In applying the recommended standards, companies should consider both physical, environmental and interface-based hazards to users and patients when conducting a risk assessment. FDA recommended factors that are independent of users include but are not limited to:

  • Harm posed by a device’s physical design such as sharp edges
  • Dangers of internal components and combustible materials
  • Likelihood of interference with other electronic devices

The goal of the guidance document is to help medical device manufacturers properly assess and mitigate risk and harm to patients by providing standardized test considerations.

Other hazards and risks to patients are directly traceable to user interaction and experience with a given medical device, including but not limited to:

  • How the user understands and perceives the device
  • Habits associated with real-world usage
  • User intuition and expectations that runs counter to a device’s interface

The guidance document places a particular emphasis on the user interface, including all of the points at which patients and clinicians interact with the device. Such touch-points, include everything from removing the packaging, to reading the instructions and using the device and everything in between. Medical device manufacturers need to understand that the development of user-friendly risk-averse medical devices and interfaces is a iterative process.

All of the assumptions and intended use of the medical device must be tested agains the real world usage of prospective users prior to marketing the device, if companies are to take serious steps towards mitigating risk and harm and reducing liability.

The FDA defines Human Factors Engineering As:

The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use.

According to the FDA, human factors testing processes are a vital component of the overall medical device product development cycle.

Pre-Market Notification: 510(k)

Companies are not currently required to follow the recommendations. However, implementing them at this stage may increase the likelihood of gaining FDA approval or clearance. The Center for Devices and Radiological Health (CDRH) at the FDA recommends that manufacturers actively use human factors testing and validation as part of both the design and production phases.

Indeed, CDRH recommends that if the risk analysis demonstrates that harm could result to patients if clinicians or patients fail to use the device properly, the medical device company should submit human factors data in premarket submissions.

For more information about the FDA’s HFE/UE recommendation, download the guidance document.

Human Factors Medical Device FDA Guidance

Related Posts


Help Us Build an Authoritative List of SaMD Cleared by the FDA


SaMD Cleared by the FDA: The Ultimate Running List


Roundup: Bluetooth Medical Devices Cleared by FDA in 2023

White Paper

Software as a Medical Device (SaMD): What It Is & Why It Matters