The Center for Devices and Radiological Health (CDRH) posted new PPI guidance on FDA.gov on March 27, 2026.

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties

FDA is issuing this guidance to provide recommendations on when and what methods to use to collect and submit patient preference information (PPI) for a device to FDA. This guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit PPI to aid in FDA-decision making across the total product life cycle. This guidance provides clarity on when and in what contexts different methods are best applied. This guidance supersedes FDA’s guidance “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.” Read more…

Patient Preference Information (PPI) in Medical Device Decision Making

The Center for Devices and Radiological Health (CDRH) recognizes that it takes many people to evaluate and communicate the benefits and risks of medical devices. However, only patients and their caregivers who have lived with their medical conditions and use medical devices understand the factors that impact their health care choices and the patients’ perspectives are critical to understanding the impact of medical devices on their daily lives. Read more…