The FDA CDRH issued final guidance on human factors information for medical device marketing submissions, establishing a risk-based framework applicable to 510(k) premarket notifications, De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDEs). The guidance clarifies expectations for human factors documentation, enabling manufacturers to provide appropriately scaled submissions based on device risk. By streamlining requirements, the guidance reduces regulatory burden while maintaining submission quality and ensuring proper risk mitigation in device design and usability.

This final guidance document assists sponsors and other stakeholders in collecting, validating, and integrating patient preference information (PPI) to support regulatory decision-making across the complete product lifecycle. The document specifies methodological approaches to study design, data validation, and strategic incorporation of PPI throughout development, premarket review, and post-market phases. A reference document for demonstrating patient-centered evidence in device submissions.

This final guidance from FDA CDRH provides comprehensive premarket recommendations for medical devices bearing weight loss indications. The document addresses device classification, non-clinical and clinical testing protocols, performance standards, and labeling requirements. Manufacturers should consult this guidance when designing clinical study protocols and compiling premarket submissions to ensure alignment with FDA's current expectations for evidence generation and regulatory documentation.