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Guidance on Applying Human Factors to Devices


Federal Register Notice: FDA is making available a guidance entitled Applying Human Factors and Usability Engineering to Medical Devices. Its purpose 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. The recommendations in this guidance are intended to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm. To download this guidance, click here. To view this notice, click here.