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FDA Issues Draft Guidance on Content of Human Factors Information in Medical Device Marketing Submissions

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Content of Human Factors Information in Medical Device Marketing Submissions. Human factors and usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors and usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and that users can use the device safely and effectively.

The draft guidance:

• provides a risk-based framework to guide manufacturers on the human factors information that should be included in a marketing submission to the FDA.

• provides our current thinking on this topic based on stakeholder feedback regarding the draft guidance “List of Highest Priority Devices for Human Factors Review.”

• is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance under docket number FDA-2015-D-4599 at www.Regulations.gov by March 9, 2023 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.