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.
US Federal Register - FDA Guidance Notices · May 29, 2026
Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and FDA Staff
Original title: Content of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
FDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.