Human Factors Testing: Is it Required by the FDA for My Product?

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Managing the Risk of Use Error is the Key Factor

Designing Usable Devices

Clients often ask us, "Is Human Factors actually required by the Design Controls process?" Or, "How much Human Factors testing is necessary to pass FDA inspections?" We advise medical manufacturers to always examine their use error risk management process, that is, how they intend to identify and mitigate the effect of errors that users may make in the process of interacting with their medical device. The phrase "identify and verify that the device has addressed user needs" appears throughout the paragraphs of Design Controls. User need fulfillment includes both the clinical outcome and the process of allowing the user to successfully carry out the tasks and steps that lead to that clinical outcome.

The questions manufacturers must ask are:

1. How were use errors systematically identified throughout the Design Controls process?

2. What steps were taken to control these use errors and how were these controls validated through user testing?

3. What test process and acceptance crieteria were used to validate that user needs, including steps necessary to operate the device safely, were successfully met?

There is no established formula or precise templates for answering these questions. The QSR Design Controls paragraphs do not explicitly call out Human Factors as being required, however, the FDA will seek processes that directly address the above three questions, and human factors methods, specifically task analysis, usability testing, and application of human factors design standards are the accepted methodologies per published FDA guidances.

The priority for the manufacturer lies in limiting risks and liabilities should a use error lead to an adverse event or surface through a warning letter from the FDA. These are times when a solid documentation and testing process for understanding and limiting use errors will be a major asset.

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