FDA Patient Preference Information (PPI) for Medical Devices: 2026 Final Guidance on Incorporating Patient Voices in Regulatory Decision-Making

Why Patient Preference Information Matters for Medical Device Submissions

On March 30, 2026, the FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued the final guidance "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." The guidance supersedes the August 2016 final guidance on the same subject and represents a decade of accumulated experience at the FDA with patient preference data. It is a significant expansion: where the 2016 guidance was limited to PMA, HDE, and De Novo submissions, the 2026 guidance now extends PPI to 510(k) submissions, Investigational Device Exemption (IDE) applications, Breakthrough Device designation requests, and even administrative and enforcement actions.

Patient Preference Information, or PPI, is quantitative or qualitative information about the relative desirability or acceptability of specified benefits, risks, and other features of a medical device from the patient's perspective. It answers questions like: How much risk are patients willing to accept for a given level of benefit? Which outcomes matter most to patients? Do patients value certain device attributes differently from how clinicians or regulators assess them?

The reason PPI matters is that regulatory decision-making at the FDA has traditionally relied on clinical data and physician input, with relatively limited systematic input from patients themselves. For devices where multiple treatment options exist and none is demonstrably superior for all patients — such as obesity treatments, orthopedic implants, or cardiac devices — understanding patient tolerance for risk and patient prioritization of different outcomes can meaningfully inform benefit-risk assessments. The FDA has published real-world examples: CDRH sponsored a PPI study on weight-loss device treatments for obesity that included more than 500 patients designed to represent a cross-section of the U.S. obese population, providing quantitative data on patient risk tolerance that helped inform device review decisions.

PPI remains entirely voluntary. The guidance does not create new obligations, does not change any standards for marketing authorization, and does not require manufacturers to collect or submit PPI. Its practical significance is the expanded landscape it creates for sponsors who choose to invest in PPI evaluations. FDA encourages sponsors to view PPI as a cumulative, iterative dataset rather than a one-time submission, building patient preference evidence that can inform clinical trial design and regulatory decisions across the total product life cycle.

This guide covers the key changes in the 2026 guidance, when PPI is most useful, how to design and conduct PPI studies, what to include in your submission, and how PPI aligns with global regulatory frameworks including the EU MDR and IVDR.

What Changed from the 2016 Guidance

The 2016 guidance was the FDA's first formal framework for incorporating patient preferences into medical device regulatory decisions. It was issued under Section 1137 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which directed the FDA to "develop and implement strategies to solicit the views of patients during the medical product development process." But the 2016 guidance was narrow in scope, applying only to PMAs, HDEs, and De Novo requests.

The 2026 guidance makes several important changes.

Expanded submission types. The guidance now covers IDE applications, Breakthrough Device designation requests, 510(k) submissions, and administrative, enforcement, and other FDA actions — in addition to the original PMA, HDE, and De Novo pathways. The inclusion of 510(k) submissions is notable because 510(k)s have not historically involved extensive benefit-risk discussions. The inclusion of administrative and enforcement actions is also significant: FDA is saying that patient preference data can be a factor in compliance and enforcement decisions, not just marketing authorization.

Total product life cycle approach. The 2016 guidance focused primarily on premarket submissions. The 2026 guidance explicitly extends to the entire device life cycle, from design and development through post-market surveillance. FDA encourages sponsors to collect and use PPI iteratively, not as a one-time data drop.

Greater methodological specificity. The 2026 guidance consolidates a decade of experience and provides more detailed recommendations on study design, data collection, and analysis methods. It addresses common questions from sponsors and provides practical recommendations for those interested in voluntary submission of PPI.

Alignment with global frameworks. The guidance aligns with increasing global emphasis on patient-centric regulation, including EU MDR/IVDR post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) principles, which also emphasize understanding patient outcomes and experiences.

When PPI Is Most Useful

The guidance identifies specific situations where PPI is most likely to be relevant and valuable.

Device characteristics that favor PPI collection:

• Devices with a direct patient interface (e.g., insulin pumps, wearable monitors, surgical implants)
• Devices intended to yield significant health or appearance benefits (e.g., aesthetic devices, weight-loss devices)
• Devices that directly affect health-related quality of life (e.g., hearing aids, prosthetics)
• Life-saving but high-risk devices where patients may accept significant risk for survival benefit (e.g., ventricular assist devices)
• Devices developed for unmet medical needs or rare diseases
• Devices offering alternative benefits to those already marketed
• Devices with novel technology
• Devices where key endpoint experiences are subjective (e.g., pain management, mental health)

FDA staff situations where PPI is particularly valuable:

• When patients may value benefits and risks differently from healthcare professionals
• When population-level differences in patient perspectives are not well understood
• When there is a significant public health impact
• When multiple treatment options exist but none is demonstrably superior for all patients
• When trade-offs between benefits and risks are preference-sensitive

The FDA has published a "List of Patient Preference-Sensitive Priority Areas" on its website, organized by clinical category. The list covers areas including bariatrics, cardiology, diagnostics, endocrinology, neurology, obstetrics/gynecology, oncology, ophthalmology, orthopedics, and others. For each area, it identifies specific benefit-risk tradeoff questions where PPI could inform regulatory decisions.

How to Design a PPI Study

The guidance provides detailed recommendations on study design methodology. PPI studies typically use stated-preference methods — structured surveys or interviews that present patients with hypothetical scenarios and elicit their preferences over different benefit and risk outcomes.

Stated-Preference Methods

The most common approaches include:

Discrete choice experiments (DCEs): Patients are presented with a series of hypothetical choice scenarios, each describing a device or treatment with different combinations of attributes (benefit levels, risk levels, other features). By analyzing the pattern of choices across many patients, you can quantify the relative importance of each attribute and the trade-offs patients are willing to make.

Threshold technique: Patients are asked to identify the minimum level of benefit they would require to accept a given level of risk, or the maximum level of risk they would accept for a given level of benefit. This directly quantifies risk tolerance.

Best-worst scaling: Patients are asked to identify the best and worst attributes from a set, providing relative rankings of different device features.

Study Design Considerations

Population selection. The study population should represent the intended patient population for the device. For FDA review, U.S. representativeness matters. The CDRH-sponsored obesity PPI study, for example, drew its sample of more than 500 patients from an online panel designed to represent a cross-section of the U.S. obese population, with demographic characteristics similar to those of obese patients in the U.S. population. The sample size was planned to capture a wide spectrum of patient preferences and provide better representativeness than anecdotal remarks.

Sample size. The guidance does not prescribe a minimum sample size, but the sample should be large enough to capture the diversity of patient preferences and provide statistically meaningful results. Subgroup analysis by demographics, disease severity, or treatment history may be important.

Instrument validation. The survey instrument should be validated to ensure it reliably measures the intended preferences. Cognitive interviewing with patients during instrument development helps ensure questions are understood as intended.

Data quality. The guidance emphasizes that FDA will evaluate the quality and relevance of PPI submitted. PPI of "requisite quality" — meaning scientifically valid, methodologically sound, and relevant to the regulatory question — can inform benefit-risk assessments.

Early Engagement with FDA

The guidance strongly encourages sponsors to engage with the FDA early through the Q-Submission (Pre-Submission) Program before committing resources to a PPI study. This is particularly important because the record of FDA actually relying on PPI in regulatory decision-making is still limited despite the real-world examples in the 2026 guidance. Sponsors should assess whether PPI is likely to be material to their submission before investing significant time and expense in a well-designed study.

Using PPI in Benefit-Risk Assessment

PPI can inform the FDA's benefit-risk assessment in several ways.

Informing clinical trial design. PPI can help identify which outcomes matter most to patients, informing the selection of primary and secondary endpoints. If patients prioritize functional improvement over symptom reduction, the clinical trial should be designed to measure both, with the primary endpoint aligned to patient priorities.

Supporting subset approvals. The guidance includes a hypothetical example of a knee implant where overall study data showed smaller-than-expected improvement, but pre-specified subgroup analysis showed greater benefit for patients with the highest pain and functional limitation. PPI confirmed that those patients found the benefits acceptable given the risks. FDA could approve the device with the indication limited to that subgroup, even when the broader population data was less favorable.

Quantifying risk tolerance. PPI can provide data on whether patients would accept the probable risks of a device given the probable benefits. If a significant number of appropriately informed patients would accept the benefit-risk profile, this can support a favorable benefit-risk assessment.

Labeling and patient information. The 2016 guidance addressed the inclusion of PPI in product labeling, and this carries over to the 2026 guidance. PPI can inform patient-facing materials about the benefits and risks of a device, helping patients make informed treatment decisions.

Important limitation. PPI does not override a negative benefit-risk determination. The guidance includes a counterexample where PPI showed some patients would accept higher risks, but FDA concluded the device posed an unreasonable risk that could be addressed through design and manufacturing improvements. In that scenario, FDA may decline to approve despite favorable PPI. PPI is one input among the totality of evidence — it does not function as a patient-demand override of the FDA's safety determination.

Alignment with EU MDR and IVDR

While the FDA's PPI guidance is specific to the U.S. regulatory framework, the principles align with increasing global emphasis on patient-centric evidence in medical device regulation.

EU MDR clinical evaluation. Under the EU MDR Article 61 and Annex XIV, the clinical evaluation must consider the state of the art and include data on clinical safety and performance. While the MDR does not explicitly require "patient preference information" as defined by FDA, the emphasis on patient-relevant outcomes and health-related quality of life is consistent with PPI principles. Manufacturers conducting clinical evaluations under the MDR can benefit from incorporating patient preference data into their clinical evaluation plans.

Post-market clinical follow-up (PMCF). The EU MDR requires post-market clinical follow-up for most devices, and the PMCF plan should address whether the clinical evidence remains sufficient to demonstrate conformity with the relevant general safety and performance requirements. Patient-reported outcomes and patient satisfaction data collected during PMCF can serve a similar function to PPI in the FDA framework, providing ongoing evidence of patient benefit and risk acceptability.

IVDR performance evaluation. Under the IVDR Article 56 and Annex XIII, the performance evaluation must include scientific validity, analytical performance, and clinical performance data. For IVDs where the clinical significance of test results depends on patient values and preferences — such as genetic tests with implications for reproductive decisions or cancer screening tests with uncertain clinical significance — PPI-type data can inform the clinical utility assessment.

Health Technology Assessment (HTA). Beyond regulatory requirements, PPI is increasingly relevant for HTA bodies such as NICE in the UK, CADTH in Canada, and G-BA in Germany. These organizations evaluate whether medical devices provide value for money and may consider patient preference evidence in their assessments. ISPOR has conducted assessments of which HTA bodies are looking at patient preference evidence and what kind of data they want to see. Coming to the table with quantitative preference data can strengthen the case for coverage and reimbursement.

Practical Recommendations for Manufacturers

For Premarket Submissions

1. Assess whether PPI is relevant to your device. If your device has a direct patient interface, involves preference-sensitive decisions, or is being developed for an unmet medical need, PPI is more likely to be useful.

2. Engage FDA early. Use the Q-Submission Program to discuss your PPI study plan before investing in data collection. Ask whether PPI is likely to be material to your specific submission type and device.

3. Design a scientifically valid study. Use stated-preference methods with validated instruments. Ensure your sample is representative of the intended patient population. Document your methodology thoroughly.

4. Integrate PPI into your benefit-risk summary. In your submission, explicitly connect the PPI findings to the benefit-risk assessment. Explain how patient preferences inform the overall safety and effectiveness evaluation.

5. Consider PPI iteratively. Build PPI collection into your clinical development plan from the start. Early PPI can inform trial design. Later PPI can support the marketing submission. Post-market PPI can support labeling updates and PMCF.

For Post-Market Surveillance

1. Collect patient outcome data. Patient-reported outcomes and satisfaction data collected during routine follow-up can serve as ongoing PPI evidence.

2. Use PPI to inform labeling updates. If post-market PPI reveals that patients value certain benefits differently than expected, consider whether labeling should be updated to reflect patient-relevant information.

3. Incorporate PPI into PMCF plans. For EU MDR compliance, include patient preference endpoints in your PMCF plan where relevant.

Key Takeaways

The 2026 FDA guidance on Patient Preference Information is a significant evolution from the 2016 version, expanding the scope to the total product life cycle and to a broader range of submission types. PPI remains voluntary and does not change any review standards, but for sponsors who invest in high-quality PPI studies, it can meaningfully strengthen benefit-risk arguments, support subset approvals, inform clinical trial design, and improve patient-facing labeling.

The guidance is a clear signal that the FDA is moving toward more patient-centric regulatory decision-making. Manufacturers should assess whether PPI is relevant for their devices and consider building PPI into their regulatory strategy from the earliest stages of development. For global manufacturers, PPI principles align with EU MDR/IVDR requirements for patient-relevant evidence and can support HTA submissions for coverage and reimbursement.