FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…
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