Guidance on Incorporating Voluntary Patient Preference Information
Summary
The FDA has issued updated guidance on incorporating voluntary patient preference information (PPI) into medical device submissions. This guidance provides recommendations on methods and contexts for collecting and submitting PPI to aid FDA decision-making throughout the total product lifecycle for biologics and medical devices.
What changed
The FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research have issued updated guidance concerning the collection and submission of voluntary patient preference information (PPI) for medical devices. This guidance supersedes a previous version and aims to clarify when and how sponsors should gather and present PPI to inform FDA decision-making across the entire product lifecycle. It covers biologics and medical devices, offering recommendations on appropriate methods and contexts for PPI submission.
Compliance officers for medical device and biologics manufacturers should review this updated guidance to understand the current recommendations for incorporating patient preference data into their submissions. While the guidance is voluntary, it provides a framework for enhancing the value of patient input in regulatory reviews. The document is open for comments at any time, with the docket number FDA-2015-D-1580 available for submissions.
What to do next
- Review updated FDA guidance on patient preference information for medical devices and biologics.
- Assess current practices for collecting and submitting patient preference data against new recommendations.
- Consider incorporating patient preference information into future submissions as appropriate.
Source document (simplified)
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Guidance Documents
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.”
Submit Comments
Submit Comments Online 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.
- ## Content current as of:
03/27/2026
Regulated Product(s)
- Biologics
- Medical Devices
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