Comments Regarding Content of Human Factors Information in Medical Device Marketing Submissions

CHPA supports FDA’s continued efforts to provide guidance on human factors information for inclusion in device premarket submissions. CHPA also generally agrees with the Agency’s risk-based approach in defining different categories of human factors information for submission in device premarket submissions, and the types of considerations outlined in the Draft Guidance that may impact which category of information is appropriate for a particular submission. But when finalizing the Draft Guidance, CHPA strongly encourages FDA to provide further clarity regarding the appropriate human factors information in premarket submissions that involve a change from prescription use to over-the-counter (“OTC”) use and associated changes from a predicate device as compared to modifications to a sponsor’s own device.