USFDA Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle was issued on 30 March 2026, updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments.

The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluating medical devices.

Patient input, particularly patient preference information (PPI), is considered part of patient experience data, which helps inform regulatory decision-making throughout the total product life cycle.

This guidance encourages stakeholders to incorporate patient perspectives and outlines how such data can be used to support benefit-risk evaluations, regulatory submissions, and device labeling.

Patient Preference Information (PPI) refers to qualitative or quantitative assessments of how patients value different treatment options, benefits, risks, or outcomes.

Scope:

This guidance applies to the voluntary submission of patient preference information for medical devices.

While PPI is not mandatory, it can be highly valuable, particularly when:

• Multiple treatment options exist without a clearly superior choice

• Evidence is uncertain across patient populations

• Patient perspectives on benefits and risks vary significantly

PPI can support decision-making by:

• Identifying unmet medical needs

• Informing clinical trial endpoints

• Evaluating benefit-risk trade-offs

• Understanding variability in patient preferences across populations

Importantly, this guidance does not change regulatory standards but provides recommendations for integrating patient perspectives into existing frameworks.

Including Patient Input in FDA Decision-Making

PPI is distinct from patient-reported outcomes (PROs), as PROs describe a patient’s health status while PPI focuses on choices between treatment options. Patient input can influence FDA decision-making by providing insights into disease burden, identifying outcomes that matter most to patients, and supporting benefit-risk assessments. The FDA may consider PPI across multiple regulatory pathways, including investigational device exemptions, premarket approvals, De Novo requests, 510(k) submissions, and post-market decisions.

Designing Patient Preference Studies

Sponsors designing patient preference studies should clearly define study objectives, research questions, study design, target population, and methods for data collection and analysis. Engaging with patients during study design is important to ensure relevance and clarity. Effective studies should be patient-centered, scientifically robust, and representative of the intended population, while also ensuring that communication of benefits, risks, and uncertainties is clear and understandable. Additionally, studies should capture heterogeneity in patient preferences, as different patient groups may have varying levels of risk tolerance and expectations.

Recommendations and Practical Considerations

High-quality patient preference studies should be relevant to regulatory decision-making, use appropriate methods for eliciting preferences, maintain logical and consistent design, and include robust statistical analysis. Effective communication of benefits and risks is critical, especially considering varying levels of patient health literacy, and should use formats that enhance understanding and minimize bias.

References

For complete official guidance, refer to:

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle – FDA Guidance