A decade later, FDA updates its patient preference information guidance for medical devices

The 2026 guidance consolidates FDA's thinking after a decade of experience with PPI. Two practical observations are worth noting:

• Clarified scope across the product life cycle. The 2026 guidance confirms that PPI can be relevant across a broad set of regulatory pathways and decision-making contexts, from informing device and study design through premarket review and into postmarket enforcement and compliance determinations.

The guidance now expressly recognizes PPI’s relevance to 510(k) submissions, noting that PPI “may be an informative and helpful factor when FDA considers the risk profile (relative to a predicate) of the new device” and expanding PPI’s potential role to all major premarket pathways for medical devices and biologics. The guidance reports two examples of how FDA considered PPI in regulatory decision-making. In one, a manufacturer used a threshold-technique PPI study of 142 patients to support a 510(k) clearance expanding a device’s indication to solo home hemodialysis, without a caregiver present, based on demonstrated patient willingness to accept the increased risks of unassisted use in exchange for increased treatment accessibility. In another, a parent-preference PPI study established the primary effectiveness endpoint used in the clinical study supporting the PMA for a novel pediatric ear tube system. These real-world examples, absent from the 2016 guidance, offer some evidence that PPI can influence regulatory outcomes, including 510(k) notices.

PPI may also be relevant, FDA says, to benefit-risk assessments in “decisions involving administrative, enforcement, and other actions,” such as “evaluating whether patients and caregivers adequately understand related benefits and risks, and information that may be available regarding patient preferences for availability of nonconforming or non-compliant devices.” The elevation of PPI to a recognized input in enforcement and compliance decisions pushes it beyond the postmarket contexts contemplated by the 2016 guidance, which were limited to informing labeling, patient communications, and postmarket redesign or indication expansion. The 2026 guidance does not, however, create a PPI-driven framework for FDA-initiated postmarket surveillance studies or recall determinations.

• Substantially enhanced methodological guidance. The 2026 guidance gets considerably more granular on PPI study design than its predecessor.

Beyond elaborating on numerous topics addressed in the 2016 guidance (e.g., logical soundness, robustness of analysis, good research practices), FDA advises sponsors developing a fit-for-purpose PPI study to tailor their study objective, research question, preference parameters, design, and method to the relevant decision context and life cycle stage. It also adds an attribute-development process that sponsors should coordinate with FDA early and treat as foundational to a study's utility. A PPI study built on attributes that FDA considers incomplete (e.g., omission of a key benefit or risk) or misaligned with clinical endpoints may carry little weight in its decision-making, FDA cautions. Attributes irrelevant to FDA decision-making, such as cost, should be excluded from studies designed for that purpose, and “[e]xtrapolation of patient preference data beyond the levels included in the study is generally not considered a valid practice.” Finally, a new standalone Appendix B addresses the major quantitative preference elicitation methods—including discrete choice experiments, threshold technique, and swing weighting—with practical guidance on method selection and sample size considerations.

* * *

The 2026 guidance does not create new obligations for device sponsors, and PPI remains voluntary. Its practical significance is the expanded landscape it creates for sponsors who are already investing, or considering investing, in PPI evaluations. FDA encourages sponsors to view PPI as a cumulative, iterative dataset rather than a one-time submission. Sponsors who develop PPI of “requisite quality” can use it to inform clinical trial design and ultimately FDA benefit-risk assessments across a range of contexts.

That said, PPI remains an evolving area, and the record of FDA actually relying on PPI in regulatory decision-making is limited despite the real-world examples in the 2026 guidance. This is particularly true for 510(k) submissions, which have not historically involved extensive benefit-risk discussions. Sponsors weighing whether to invest in a well-designed PPI study, which can involve significant time and expense, should engage FDA early through the Q-Submission Program to assess whether PPI is likely to be material to their submission before committing resources. The guidance is a meaningful signal of FDA’s direction and in line with increasing emphasis on patient-centric healthcare, but it remains to be seen how consistently the agency will rely on PPI in practice and balance this information against safety and efficacy results.

Authored by Kristin Zielinski Duggan and Lina Kontos.