Patient engagement refers to the intentional, meaningful interactions with patients that provide opportunities for mutual learning and effective collaborations. 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 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' views on living with a medical condition and the associated treatments and diagnostic procedures involved in managing their condition may offer insights different from those of healthcare providers, manufacturers, and regulators.
Patient engagement will help 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 at all stages of the medical device product life cycle including:
- Designing medical devices
- Planning and conducting medical device clinical investigations
- 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 approaches to conduct patient engagement events that 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|
|Patient Engagement Advisory Committee (PEAC)||CDRH established this advisory committee to help assure that the needs and experiences of patients are included as part of the FDA's deliberations on complex issues involving the regulation of medical devices and their use by patients. Scientific topics discussed may include, patient preference study design, benefit-risk communication, device labeling, unmet clinical needs, patient-reported outcomes, and device-related quality of life measures. It is the first and only FDA advisory committee whose members are all patients, caregivers, and representatives of patient organizations.|
|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 with using medical devices.|
|Community 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.|
|Public Health Symposiums||CDRH's symposiums offer multidisciplinary perspectives on a health condition or device treatment through collaborative communications between CDRH staff, external subject matter experts, care partners, and patients or patient groups.|
|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 other offices in the FDA, such as the Patient Affairs Staff 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 Investigations draft 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.
- If you have questions about patient engagement opportunities at CDRH, email CDRH_PatientEngagement@fda.hhs.gov.