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On February 19, 2016, the FDA held a webinar for industry to review the Applying Human Factors and Usability Engineering to Medical Devices guidance document. This guidance will assist medical device developers in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environment. The FDA recommends that manufacturers include human factors data in their premarket submissions (i.e., PMA, 510(k)) if an analysis of risk for the device indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm.

Target Audience: Industry

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health