2 Human Factors Medical Device Guidances Out

FDA has issued two guidances dealing with human factors in medical devices. The first, a draft guidance, List of High Priority Devices for Human Factors Review, is to inform medical device manufacturers which device types should have human factors data included in premarket submissions. The document says that the agency believes that the specified device types have clear potential for serious harm resulting from use error, and that review of human factors data in premarket submissions will help it evaluate the safety and effectiveness and substantial equivalence of these devices.

The second document, Applying Human Factors and Usability Engineering to Medical Devices, is to assist industry 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 environments. It says that its recommendations are intended to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm. “FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use,” it says.