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

Date

May 29, 2026

Category

US Regulations

Description

The FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions” on May 29, 2026. The guidance introduces a risk-based framework to help manufacturers determine what human factors engineering and usability engineering information should be included in FDA submissions.

A notable addition of the guidance is the inclusion of a clear decision flowchart to determine whether human factors validation data should be submitted. The flowchart clarifies that the presence of critical tasks, or modifications that impact critical tasks, does not automatically require the submission of a full human factors validation study. Instead, FDA applies a risk-based assessment considering the device’s history of safe use, the complexity of the user interface, and the adequacy of existing risk-control measures. Where appropriately justified, manufacturers may provide a rationale for not submitting new human factors validation data, supported by objective evidence that the existing risk controls remain effective. 

NSF can support medical device manufacturers in interpreting the new guidance, assessing the appropriate human factors submission category, and preparing robust, FDA-ready human factors documentation.