Date of Publication: 30-Mar-2026
INTELLIGENCE OVERVIEW
Agency: USFDA
The U.S. FDA has released guidance highlighting how Voluntary Patient Preference Information (PPI) can support regulatory decision-making for medical devices across the total product life cycle (TPLC). The document emphasizes that patient perspectives on benefits, risks, treatment trade-offs, and meaningful outcomes can provide valuable input during device development, clinical evaluation, and post-market decision-making.
The guidance explains that submission of PPI is voluntary, but may be especially useful for devices involving high-risk benefit-risk trade-offs, novel technologies, quality-of-life outcomes, unmet medical needs, and patient-facing use scenarios. It also outlines key considerations for designing robust patient preference studies, including study objectives, research questions, patient-centeredness, appropriate methods, and relevance to FDA decision contexts.
FDA also encourages early engagement with the Agency when planning and developing PPI studies, particularly to align on study design, attributes, patient population, and survey methodology. The guidance reinforces the growing role of patient-centric evidence in shaping more informed and meaningful medical device decisions.
KEYWORDS: Clinical Evaluation, Patient Evidence, Medical Devices
REFERENCE: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/incorporating-voluntary-patient-preference-information-over-total-product-life-cycle-0