Patient preference information (PPI)

FDA may consider PPI in benefit-risk decisions on premarket submissions, for example when patients accept a higher risk for a meaningful benefit. Submitting it is voluntary, and it carries weight only when it comes from well-designed studies.

the qualitative or quantitative assessment of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.

FDA guidance: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August 2019), Section IV.C, Additional Factors in the Assessment of the Probable Benefits and Risks of Devices (Patient perspectives)