> ## Content Index
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# Device Trials and Patient Engagement Guide
- URL: https://www.fdaweb.com/device-trials-and-patient-engagement-guide/
- Published: 2019-09-23T12:00:00.000Z
- Updated: 2026-09-15T01:51:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145062

FDA has released a [draft guidance](https://www.fda.gov/media/130917/download?ref=fdaweb.com) entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The document is intended to help sponsors with how they can use patient engagement to understand experiences, perspectives, and other relevant information from patient advisors. It is also intended to improve the design and conduct of medical device clinical investigations, and highlight the benefits of engaging with patient advisors early in the medical device development process.