Abstract

Congratulations to the authors for providing valuable insights into the US Food and Drug Administration (FDA)’s early experience after issuing formal guidance in 2016 on incorporating patient preference information (PPI) into medical device decision making.¹ The commentary is well written and accessible to a variety of stakeholders interested in PPI and medical device review. The authors emphasize 3 key recommendations based on the PPI guidance:

• To inform benefit-risk assessments, PPI studies should be “all about patients.”
• Researchers should interact with the Center for Devices and Radiological Health (CDRH) early about the design, attributes, and analyses.
• Researchers should seek opportunities to design efficient clinical investigation studies based on the learnings of PPI studies.