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# Guide on Patient Engagement in Device Trial Designs
- URL: https://www.fdaweb.com/guide-on-patient-engagement-in-device-trial-designs/
- Published: 2022-01-26T12:00:00.000Z
- Updated: 2026-09-14T17:30:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151006

*Federal Register* notice: FDA is making available a final guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” The document was developed based on a recommendation by the agency’s Patient Engagement Advisory Committee for a framework to clarify how patient advisors can engage in the clinical investigation process. It focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-01-26/pdf/2022-01374.pdf?ref=fdaweb.com).