List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "List of Highest Priority Devices for Human Factors Review." FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions.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 FDA evaluate the safety and effectiveness and substantial equivalence of these devices. This draft guidance is not final nor is it in effect at this time.