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FDA Human Factors Guidance Revealed

A draft of FDA human factors guidance has been published. It discusses methods for integrating human factors into product development, sample size requirements for usability testing, and comparison with IEC 62366-1. We will discuss these topics in detail to understand their implications for product development and design. Read on for more information!

Draft FDA Human Factors Guidance

The FDA recently released the Draft Human Factors Guidance (HFG) for medical devices and combination products. This document outlines the current expectations of the agency for HF testing, clinical considerations, usability engineering, and user error. It is essential for manufacturers of medical devices and combination products because of the possible public health risks associated with user error. The guidance will also assist manufacturers in their premarket submissions and HFE/UE-related processes.

The Draft FDA human factors guidance for combination products includes examples of simulated and actual usability studies. In addition, the guidance states that the final marketing submission must consist of a report of human factors testing. To understand what constitutes a good report, consult the draft guidance. While reporting exceptions to existing regulations, the FDA recommends that a company submit complete information to the agency. The advice is only applicable to national and international manufacturers of class II and class III products.

Methods for integrating human factors into product development

To make the most of the potential benefits of human factors, product designers must integrate them into the development process from the concept stage to production. A human factors analysis can identify opportunities for use-error mitigation through labeling, training, and monitoring product use events. However, conducting human factors studies can compress the development timeline. To minimize costs and risks, early data collection is crucial. This article will provide an overview of some methods for integrating human factors into product development.

Methods for incorporating human factors into product development consider psychological, cultural, and perceptual factors. They can make the difference between life and death. For instance, certain products rely on color or shape to suggest an immediate response. For colored-blind users, this may mean choosing a different product design. Also, keyboards must be spaced appropriately to improve operation and safety. Finally, in the case of dangerous equipment, human factors scientists should consider the safety and effectiveness of these devices.

Sample size requirements for usability testing

The sample size requirements for usability testing in FDA Human Factors Guidance state that there should be a minimum of 15 participants per major group to identify 90% of usability issues. However, some experts suggest that there should be fewer participants. Here, we review the sample size requirements in the FDA Human Factors Guidance to learn more about the importance of this research methodology. Also, we look at the FDA’s “Grounded Procedure” and what it means for your product.

FDA’s guidance notes that sample size requirements should be based on the number of users. However, a small number of participants may not be sufficient for identifying usability issues. For example, in the Faulkner study, the sample size was only 15 people, and the authors found that a larger sample would yield more accurate results. In this way, the FDA’s guidance on usability testing provides a middle ground between the two approaches.

Comparison with IEC 62366-1

The IEC 62366-1:2015 standard for human factors is very similar to the guidance published by the FDA for human factors in medical devices. For example, it establishes a safety cutoff line and talks about how long a device should last before it becomes unsafe to use. However, the FDA’s Human Factors Draft Guidance focuses on a machine’s life cycle and its uses.

In addition, IEC 62366-1:2015 incorporates the UOUP section, which describes post-market material. This post-market material must include instances of product hazards and customer complaints. For example, a blood glucose meter for OTC use must undergo a 350-person lay-user study. A Covid-19 self-test, on the other hand, must go through a 30-person usability study.

The IEC 62366-1:2015 standard does not define the term “abnormal” but includes broader definitions of what constitutes an “abnormal” use. However, the FDA considers intentional actions that go beyond standard service. Therefore, this definition also includes intentional acts or omissions that may not be considered reasonable under the circumstances. In addition, IEC 62366-1:2016 proposes to redefine the term “use” in terms of human factors. As such, it captures all instances of medical device use, including mistakes or misuse.