US medical device regulators have specified types of devices for which premarket application submissions should include human factors testing information, according to new Food and Drug Administration guidance.

The FDA guidance explains that devices it identifies warrant human factors data because of “clear potential for serious harm resulting from use error.” Such data is necessary for proper evaluation of safety, effectiveness and substantial equivalence, states the agency.

Premarket applications for the following device types should include human factors testing reports unless applications pertain to the same users, user tasks, interfaces and environments as their predicate devices:

A separate guidance on human factors and usability engineering provides further details on what to include in premarket submissions for these and other device types that may pose serious harm if used incorrectly.