> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Issues Patient Preference Info Guidance
- URL: https://www.fdaweb.com/fda-issues-patient-preference-info-guidance/
- Published: 2016-08-23T12:00:00.000Z
- Updated: 2026-09-14T21:26:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136581

FDA has published a 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*, explaining the principal concepts for sponsors and other stakeholders to consider when choosing to collect patient preference information (PPI), which may inform FDA’s benefit/risk determinations in the premarket review of PMAs, HDE applications, and *de novo* requests. The [document](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTYwODIzLjYyODgxMjMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDgyMy42Mjg4MTIzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MzM4NzQwJmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446680.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) is applicable to both diagnostic and therapeutic devices that are subject to the review processes.

“FDA values the experience and perspective of patients,” the guidance says. “The agency understands that patients and care-partners who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights into and perspectives on the benefits and risks of devices reviewed under the premarket approval, humanitarian device exemption, or *de novo* classification pathway. FDA believes that patients can and should bring their own experiences to bear in helping the agency evaluate the benefit-risk profile of certain devices.”

The guidance’s objectives are to: 

- encourage submission of PPI, if available, by sponsors or other stakeholders to FDA and to aid in FDA decision making;
- outline recommended qualities of patient preference studies, which may result in valid scientific evidence;
- provide recommendations for collecting and submitting PPI to FDA; and
- discuss FDA’s inclusion of PPI in its decision summaries and provide recommendations for including such information in device labeling.

The policy in the guidance, FDA says, is consistent with an earlier benefit-risk guidance.