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# Guidance on Device Patient Preference Info
- URL: https://www.fdaweb.com/guidance-on-device-patient-preference-info/
- Published: 2016-08-24T12:00:00.000Z
- Updated: 2026-09-14T21:26:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136599

*Federal Register* Notice: FDA is making available a guidance entitled *Patient Preference Information — Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling*. This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information, which may inform FDA’s benefit-risk determinations in the premarket review of PMAs, HDE applications, and de novo classification requests. It also discusses FDA’s inclusion of patient preference information in its decision summaries and provides recommendations for including such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, originally issued on 3/28/12, that has been edited to be consistent with this guidance document. To download this guidance, click [here](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446680?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20221.pdf?ref=fdaweb.com)