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# Draft Device Human Factors Guidance
- URL: https://www.fdaweb.com/draft-device-human-factors-guidance/
- Published: 2022-12-08T12:00:00.000Z
- Updated: 2026-09-14T18:09:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153355

FDA has published a draft guidance, *Content of Human Factors Information in Medical Device Marketing Submissions*, with recommendations for the content of human factor and usability engineering information to be included in marketing submissions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions?ref=fdaweb.com) says a marketing submission should, where appropriate, demonstrate that the needs of the intended users were considered in the device design and that the device is safe and effective for the intended users, uses, and use environment.

The guidance includes Introduction, Scope, Definitions, Risk-Based Approach to Human Factors Engineering Information in Marketing Submissions. Recommended Content of Human Factors Information in Marketing Submissions, and Examples.