CDRH Patient Engagement Courses
UPDATE: June 1, 2026
As of June 1, 2026, the first CDRH-developed Patient Education Course is available for patients, caregivers, patient organizations and industry and health care stakeholders who are interested in learning how to more effectively engage with the FDA and Medical Device Developers. To access the YouTube video of the course “Patients as Advisors in Medical Device Clinical Studies,” please click on the link in the section below the subheading: “How Does CDRH Work with Others to Encourage Engagement with Patients?”
- Division of Patient-Centered Development
- Patient Preference Information (PPI) in Medical Device Decision Making
- Clinical Outcome Assessments (COAs) in Medical Device Decision Making
- CDRH Patient and Caregiver Connection
- CDRH Patient Engagement
- Engaging Patients Is Part of CDRH Culture: Videos
- Best Practices for Communicating Cybersecurity Vulnerabilities to Patients
Patient engagement refers to intentional, meaningful interactions with patients that provide opportunities for mutual learning and continued effective collaboration. These partnerships with patients help CDRH advance the development and evaluation of innovative medical products and monitor the performance of marketed devices.
Why Does CDRH Engage with Patients?
Patients are experts in their medical conditions and offer valuable information about living with the condition and its treatments that can significantly impact the development, evaluation, and monitoring of medical devices.
Patients' experiences living with a medical condition and the associated treatments as well as diagnostic procedures involved in managing their condition may offer insights different from those of healthcare providers, manufacturers, and regulators.
Patient engagement helps CDRH better understand the experiences and perspectives of the people who will ultimately benefit from the medical devices that it regulates.
Benefits of hearing from patients could be experienced early and throughout all stages of the medical device product life cycle including:
- Designing medical devices
- Planning and conducting medical device clinical studies
- Informing CDRH's thinking on current issues impacting a patient community
- Helping to identify emerging signals
- Communicating safety messages
- Identifying specific populations' perspectives on benefit-risk for a given treatment
What Are Some Ways That CDRH Engages with Patients?
CDRH has developed many mechanisms to conduct patient engagement events and help its staff engage with patients. Patients and caregivers may participate in these events in-person, by phone, or online.
| CDRH Patient Engagement Activities | Details |
|---|---|
| CDRH Patient and Caregiver Connection | CDRH developed this program to provide its staff with timely access to patients and caregivers who are willing to share their individual experiences living with their disease or condition and their experiences using medical devices. |
| Patient Engagement Town Hall | CDRH-sponsored town halls are open to all CDRH staff. Patient engagement topics can be broad and not necessarily focused on a specific medical condition, disease, or device. The format of the town hall is flexible and may include a panel of experts, a series of presentations, an exhibition, and a listening session. |
| Patient Group Conversations | CDRH invites patients or patient groups to share their health experiences and respond to interactive questions about their condition, treatment, participation in clinical trials, or use of medical devices. These sessions allow for open dialogue between CDRH and a small group of patients or representatives of patient groups. |
How Does CDRH Work with Others to Encourage Engagement with Patients?
- CDRH works collaboratively with patients, caregivers, patient organizations and industry and health care stakeholders who are interested in learning how to more effectively engage with FDA and Medical Device Developers through offering a series of courses. To access the initial course, “Patients as Advisors in Medical Device Clinical Studies”, please click on this link.
- CDRH works collaboratively with other offices in the FDA, such as the Public Engagement Staff within the Office of External Affairs in the Office of the Commissioner and the Patient-Focused Drug Development group in the Center for Drug Evaluation and Research.
- CDRH works with the Medical Device Innovation Consortium to advance patient engagement in clinical trials. For more information, see MDIC's Patient Engagement in Clinical Trials Survey Report and Literature Review.
- CDRH encourages the medical device industry to consider engaging with patients in the design and conduct of clinical investigations. For more information, see the Patient Engagement in the Design and Conduct of Medical Device Clinical Studies final guidance.
- For formal input on proposed engagement efforts with patients in the design of medical device clinical studies, see Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
Additional Information
Contact Us
- If you have questions about patient engagement opportunities at CDRH, email CDRH_PatientEngagement@fda.hhs.gov.