Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties

Issue Date: March 30, 2026
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final

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.”

Download the Guidance Document