Patient advocacy and engagement have evolved into critical aspects of healthcare development and management in recent years, as patient and care partners seek greater involvement in treatment evaluation and decision making. The FDA recognizes and supports this through its Patient Preference Initiative, which includes the recently released guidance on “Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders”. While the FDA stresses the benefits and value of PPI, which reviewers, industry, patient groups, and other stakeholders are also encouraged to collect and analyze for additional information, they also recognize that PPI is not useful or necessary for all devices and must be utilized under the proper conditions.

• Discussing key considerations and definitions in final guidance
• Preference sensitive–when PPI is informative for regulatory decision making
• Recommended qualities/characterizes of PPI included in clinical studies
• Appropriate techniques for gathering data with practical examples
  • Data generation
  • Documentation

 

Speakers:
Anindita (Annie) Saha
Director, External Expertise and Partnerships
Center for Devices and Radiological Health
Office of the Center Director

Martin Ho
Associate Director for Quantitative Innovation
Center for Devices and Radiological Health
Office of Surveillance and Biometrics