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# FDA Guide on Patient Preferences in Device Submissions
- URL: https://www.fdaweb.com/fda-guide-on-patient-preferences-in-device-submissions/
- Published: 2026-03-27T12:00:00.000Z
- Updated: 2026-09-14T13:36:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160890

FDA has issued a [final guidance](https://www.fda.gov/media/92593/download?ref=fdaweb.com) titled *Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle*.** The document was mandated under the medical device user fee program to provide insight and address common questions for those interested in the voluntary use of PPI in regulatory submissions.

The agency highlights that patient preference data has already been used in regulatory submissions. For instance, survey data supported expanding the use of a hemodialysis device to allow at-home use without a caregiver, reflecting patient demand for greater independence. In another case, a study of parents evaluating ear tube procedures for children found that many would prefer an in-office procedure over surgery under general anesthesia — provided the success rate exceeded a defined threshold. That threshold helped establish a benchmark for device performance in regulatory review.

Despite the growing emphasis on patient input, the FDA stressed that all such data must meet standards for valid scientific evidence. The guidance outlines key design considerations for manufacturers conducting PPI studies, including:

- Clear research objectives and questions
- Appropriate study design (qualitative or quantitative)
- Representative patient populations
- Careful selection of benefits, risks, and other attributes
- Robust statistical analysis

The agency also encourages sponsors to engage patients early in study design and to ensure participants fully understand the tradeoffs presented in surveys. It emphasizes that patient preferences are not uniform and may vary based on disease severity, personal circumstances, and available treatment options. As a result, studies should aim to capture a broad and representative sample of the intended patient population, including relevant subgroups. Understanding this variability can help regulators identify which patient populations may view a device’s benefits as outweighing its risks, even when others may not.

The guidance reflects a broader shift toward patient-centered regulatory decision-making, where clinical outcomes are evaluated not only by traditional endpoints but also by how patients value those outcomes relative to potential harms. While the recommendations are not legally binding, they signal the agency’s expectation that incorporating patient perspectives could play an increasingly important role in shaping medical device innovation and approval decisions.