If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device? The U.S. Food & Drug Administration (FDA) attempts to answer these questions in its recently issued draft guidance titled “Content of Human Factors Information in Medical Device Marketing Submissions” (the “Draft Guidance”). Once final, this guidance will complement and partly supersede FDA’s current guidance, “Applying Human Factors and Usability Engineering to Medical Devices” (the “Human Factors Guidance”), and supersede FDA’s draft guidance, “List of Highest Priority Devices for Human Factors Review.”
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