CPC White Paper to FDA Regarding Validating Specifications

On October 17, 2022, the CPC submitted a white paper to FDA detailing CPC’s position with respect to recent requests from FDA to demonstrate how companies have “validated” device user interface specifications in intended user population(s). The document lists specific concerns of CPC member companies and offers case study examples to highlight a range of experiences. As discussed further in the white paper, CPC seeks clarity on the Agency’s expectations for validation of product user interface specifications and confirmation of the context in which such validation expectations are applicable.