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# FDA Wants MDUFA 5 PPI Input
- URL: https://www.fdaweb.com/fda-wants-mdufa-5-ppi-input/
- Published: 2023-04-06T12:00:00.000Z
- Updated: 2026-09-14T18:24:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154158

FDA is soliciting responses to five questions as part of its commitment to meeting the MDUFA 5 performance goals by taking actions to engage patients and incorporate their perspectives in the regulatory process. An agency [notice](https://www.fda.gov/about-fda/cdrh-patient-science-and-engagement-program/patient-preference-information-ppi-medical-device-decision-making?utm%5Fmedium=email&utm%5Fsource=govdelivery) says FDA is considering revising a final 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*, to address common questions for those interested in the voluntary use of patient preference information (PPI) in regulatory submissions.

FDA says it is considering whether to add and address the following questions in the guidance revision:

- what are the important factors that a sponsor should consider when designing a patient preference study to ensure that it will address the question that it is meant to address;
- what are some methods for eliciting PPI and when might it be appropriate for sponsors to use them;
- what are important considerations for the selection of attributes and attribute levels when designing a PPI study;
- what information is important to provide to FDA about the patient preference protocol, study conduct, and PPI results to inform a medical device regulatory decision; and
- what are some examples of PPI studies that could help support medical device regulatory decisions?