# Content of Human Factors Information in Medical Device Marketing Submissions:  Guidance for Industry and Food and Drug Administration Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/content-of-human-factors-information-in-medical-device-marketing-submissions-guidance-for-industry-and-food-and-drug-administration-staff/08b681b2-5a56-4038-8e63-d7363bb78154

> FDA guidance document: Content of Human Factors Information in Medical Device Marketing Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: May 29, 2026. Get complete insights and analysis.

---

## Details

- Title: Content of Human Factors Information in Medical Device Marketing Submissions:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2026-05-29
- Last Changed: 2026-05-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-4599 ">FDA-2015-D-4599 </a>

## Related Documents

- [Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/validation-of-certain-in-vitro-diagnostic-devices-for-emerging-pathogens-during-a-section-564-declared-emergency-guidance-for-industry-and-food-and-drug-administration-staff/09c36b30-818f-4b05-8c6b-971e6b5a0a0a)
- [Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/technical-performance-assessment-of-quantitative-imaging-in-radiological-device-premarket-submissions-guidance-for-industry-and-food-and-drug-administration-staff/0ad9d5da-55b8-46ee-b2ab-37dd0c4b75b2)
- [Off-The-Shelf Software Use in Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/off-the-shelf-software-use-in-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/e6562455-523c-4460-ae34-ee4678a33a70)