This new guidance replaces the 2016 guidance directed toward PPI included in premarket submissions, which was limited to de novo, Premarket Approval (PMA), and humanitarian device exemption applications. The 2016 guidance also addressed the inclusion of PPI in product labels, a feature that is carried over into this new draft. The development of guidance related to the use of PPI in premarket applications was required by Section 1137 of the Food and Drug Administration Safety and Innovation Act of 2012. However, the inclusion of PPI in labels is not found in Section 1137.
The March 2026 guidance expands the use of PPI to include admission of a device into the breakthrough devices program along with 510(k) applications. However, CDRH stated that PPI can be used to deal with administrative, enforcement and other actions as well. The guidance states that PPI might be particularly useful when patient decisions are preference-sensitive, such as when more than one therapeutic option is available but none are demonstrably superior for all patients.
While regulated industries overseen by the Center for Devices and Radiological Health (CDRH) are the primary audience for this guidance, the Center for Biologics Evaluation and Research (CBER) is also listed as an author of the guidance. Entities that may find the guidance useful are patient groups and academic researchers conducting PPI studies.
The FDA defines PPI as qualitative or quantitative assessments of the relative desirability or acceptability of a pre-specified set of alternatives or choices in the context of health interventions. PPI is distinct from patient-reported outcomes, but PPI could include the preferences of caregivers and healthcare professionals when those perspectives are relevant to the device’s benefit-risk assessment.
Industry use of PPI is not mandatory and may not be relevant for all device types, although it may be useful when sub-populations of a patient population exhibit varying preferences. PPI can be used to inform FDA decision-making for premarket applications, but also for applications used to expand the device’s indication for use statement.
CBER and the FDA Center for Drug Evaluation and Research (CDER) recently made available a draft guidance for the patient preference study (PPS), which is based on an internationally recognized standard. This Level 1 draft guidance reflects the agency’s interest in regulatory harmonization for pharmaceuticals and biologics and is based on the E22 guidance issued by the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
ICH released the draft edition of the E22 guidance in November 2025 while FDA made its proposal to adopt E22 available for comment Feb. 6, 2026. The agency said it will accept comment on this draft guidance through April 7, 2026, and that it will reformat the E22 document to comport with the agency’s publication style, assuming it is adopted.
The scope of this draft guidance is largely limited to the use of stated-preference methods used to obtain patient preferences, such as surveys or interviews. As is the case with the PPI guidance, the draft does not address patient-reported outcomes, but sponsors can use existing PPS literature in lieu of an entirely de novo study to establish patient preferences for a premarket application.