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FDA Details When Human Factors Testing Is A Must

FDA identified the device types that almost always need human factors, or usability, data included in premarket submissions in a draft guidance posted in conjunction with final guidelines with broader human factors testing recommendations.

FDA has identified 16 device types that should almost always include human factors data in premarket submissions.

The devices, named in a draft guidance document titled "List of Highest Priority Devices for Human Factors Review," include a litany of product types that have struggled with...

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