FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help medical device manufacturers identify human factors information to include in device marketing submissions.

Issued in early December, the draft guidance, titled “Content of Human Factors Information in Medical Device Marketing Submissions,” sets out a risk-based framework intended to guide manufacturers through the process of assessing the human factors submission category applicable to a given device. The guidance includes a helpful flowchart and several checklists to facilitate the categorization process. Then, based on the submission category that has been identified, the guidance then provides detailed recommendations on the information to be included in the marketing submissions for that device.

Once finalized, the draft guidance is intended to be used in conjunction with the FDA guidance on “Applying Human Factors and Usability Engineering to Medical Devices.”

Read the FDA’s draft guidance on human factors information in medical device marketing submissions.

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