# Patient Engagement in the Design and Conduct of Medical Device Clinical Studies:  Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/patient-engagement-in-the-design-and-conduct-of-medical-device-clinical-studies-guidance-for-industry-food-and-drug-administration-staff-and-other-stakeholders/4fd69950-e1df-4bef-96df-98876c880143

> FDA guidance document: Patient Engagement in the Design and Conduct of Medical Device Clinical Studies:  Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders. Issue date: January 26, 2022. Get complete insights and analysis.

---

## Details

- Title: Patient Engagement in the Design and Conduct of Medical Device Clinical Studies:  Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2022-01-26
- Last Changed: 2022-01-25
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3846">FDA-2019-D-3846</a>

## Related Documents

- [Computer Software Assurance for Production and Quality System Software:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/computer-software-assurance-for-production-and-quality-system-software-guidance-for-industry-and-food-and-drug-administration-staff/3c846ce6-b6c7-4c31-b809-362db15d032f)
- [Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation:  Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders](https://www.globalkeysolutions.net/guidances/guidance-document/principles-for-selecting-developing-modifying-and-adapting-patient-reported-outcome-instruments-for-use-in-medical-device-evaluation-guidance-for-industry-and-food-and-drug-administration-staff-and-other-stakeholders/e5b1e628-90bc-4808-9dcf-5491e6d5c43d)
- [Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/evaluation-and-reporting-of-age-race-and-ethnicity-specific-data-in-medical-device-clinical-studies-guidance-for-industry-and-food-and-drug-administration-staff/9fb9098f-5c24-4238-a9d8-64a10ae06702)
