On Dec. 9, 2022, the U.S. Food and Drug Administration (FDA) issued a new draft guidance, “Content of Human Factors Information in Medical Device Marketing Submissions,” that provides recommendations for the inclusion of human-factors information in marketing submissions.

The drafted guidance is intended to supplement the FDA’s final guidance on Human Factors Evaluation (HFE). Once approved, the draft will replace the existing 2016 guidance.

To help you stay up to date, we’ve dug deep into the new proposed guidance to give you everything you need to know on the FDA’s human-factors guidance draft and what it could mean for your business.

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