On March 30, 2026, the Food and Drug Administration (FDA) published a final guidance entitled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.” The guidance provides updated recommendations to industry and FDA on how and when voluntary patient preference information (PPI) may be considered by FDA staff in decision making relating to devices. PPI is not required for FDA’s consideration as part of FDA decision making, but FDA may find it valuable to consider patient viewpoints when the information meets applicable legal requirements. In addition, FDA encourages industry and other interested parties to consider patient experience data in device development and evaluation, including data relating to patient preferences for outcomes and treatments. FDA acknowledges that patient perspective and personal experiences can help FDA evaluate the benefit-risk profile of certain devices throughout the total product life cycle.