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GUIDANCE DOCUMENT

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties March 2026

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-1580
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.”

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-1580.

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