Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Content of Human Factors Information in Medical Device Marketing Submissions." This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be in
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-05-29 |
| Summary | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Content of Human Factors Information in Medical Device Marketing Submissions." This guidance provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to the Center for Devices and Radiological Health (CDRH) to facilitate the efficiency of the FDA review process. |
| Document number | 2026-10734 |
| Official record | https://www.federalregister.gov/documents/2026/05/29/2026-10734/content-of-human-factors-information-in-medical-device-marketing-submissions-guidance-for-industry |