FDA Explains How Patient Preference Factors into Device Approvals

An FDA guidance document outlines how to incorporate patient preference information into the medical device development and approval process.

Sponsors and other stakeholders should meet early with their review division if they are thinking of submitting patient preference information, the guidance advises.

Additionally, "the agency may also consider obtaining its own PPI to further understand the benefit-risk factors affecting patients with diseases or conditions who may be considering using a specific device type," the guidance says.

It recommends certain qualities for patient preference studies, including patient centeredness; representativeness of the sample and generalizability of results; capturing heterogeneity of patients' preferences; minimal cognitive bias; robustness of analysis of results; study conduct; and comprehension by study participants. — April Hollis