Today, the FDA’s Center for Devices and Radiological Health (CDRH) issued the final version of the guidance, “Applying Human Factors and Usability Engineering to Medical Devices.” 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. CDRH 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.
CDRH has also issued the draft guidance “List of Highest Priority Devices for Human Factors Review” to make clear which device types are recommended to include human factors data in premarket submissions. The devices listed in this draft guidance were selected because they have clear potential for serious harm resulting from use error. If finalized, this guidance recommends human factors data is included in premarket submissions for these devices unless the submission does not involve any changes to users, user tasks, or use environments from those of the predicates. It is also recommended that submissions for device types not included in this draft guidance contain human factors data if an analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm. The draft guidance is not for implementation until final. The comment period will be open for 90 days in the Federal Register under docket number FDA-2015-D-4599.