Incorporating Patient Preference Information Across Product Life Cycle
The U.S. Food and Drug Administration (FDA) has released updated guidance aimed at strengthening how patient perspectives are incorporated into medical device decision-making throughout the total product life cycle.
Titled “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle” the guidance provides recommendations for industry, researchers, and other stakeholders on when and how to collect and submit patient preference information (PPI) to the agency.
Patient preference information refers to qualitative or quantitative assessments of how patients value different treatment options, including their tolerance for risk and expectations for benefit. The FDA emphasizes that integrating this data can enhance regulatory decisions by ensuring they better reflect patient needs and real-world experiences.
The updated guidance outlines key principles for:
- Determining when PPI is most useful in the product life cycle
- Selecting appropriate data collection methods
- Designing scientifically valid studies
- Submitting PPI to support regulatory applications
This new document supersedes the FDA’s earlier guidance, “Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests”. The revision reflects evolving best practices and growing recognition of patient-centered approaches in healthcare innovation.
