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Guidance on Human Factors Data for Devices


Federal Register Notice: FDA is making available a draft guidance entitled List of Highest Priority Devices for Human Factors Review. The agency aims to inform medical device manufacturers on which device types should have human factors data included in premarket submissions. FDA believes these 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. To download this guidance, click here. To view this notice, click here.