Integrating the Voice of the Patient Into the Medical Device Regulatory Process Using Patient Preference Information

Mar 1, 2020, 00:00 AM
Section Title : COMMENTARY
Section Order : 294
First Page : 294
The US Food and Drug Administration is one of several US and global agencies making strides to incorporate patient preference information (PPI) into its decision making. PPI has been included in 5 completed medical device marketing decisions to date. Its usage is not more widespread because of uncertainty about how to design “fit-for-purpose” patient preference studies and a lack of standards for the choice of preference elicitation methods, among other reasons. To advance the application of PPI to decision making about medical devices, the Food and Drug Administration has published a guidance document, “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.” This article discusses key concepts in the guidance document, in addition to providing lessons learned from the use of PPI for medical device regulatory applications to date and identifying new opportunities to leverage PPI to elevate the patient voice in the medical device product life cycle.
HEOR Topics :
  • Approval & Labeling
  • Health Policy & Regulatory
  • Patient-Centered Research
  • Personalized & Precision Medicine
  • Pricing Policy & Schemes
  • Specialized Treatment Areas
  • Stated Preference & Patient Satisfaction
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