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  1. CDRH Patient Engagement

CDRH Patient and Caregiver Connection

The Patient and Caregiver Connection provides patients and caregivers with an opportunity to share their experiences living with a condition or using medical devices with FDA's Center for Devices and Radiological Health (CDRH) staff who are focused on protecting and promoting public health.

What Is the Patient and Caregiver Connection?

The Patient and Caregiver Connectionis a partnership that provides CDRH staff with broad and timely access to patient and caregiver experiences. Partner organizations will collect feedback specific issues from their members and share that feedback with CDRH. This patient feedback on the impact of the medical condition on individual patients can help provide a rich context for regulatory decision-making.

Why Did CDRH Establish the Patient and Caregiver Connection?

Engaging with patients and caregivers through the Patient and Caregiver Connection enhances CDRH's ability to hear, understand, and integrate their perspectives in the course of its work.

The Center intends to work with both patients and caregivers to advance the development and evaluation of innovative medical devices and monitor the performance of marketed devices. Patient and Caregiver Connection partnerships will enable a culture of meaningful patient engagement and interaction between CDRH staff, patients, and caregivers.

How Can the Patient and Caregiver Connection Help CDRH?

CDRH developed the Patient and Caregiver Connection to obtain three types of patient feedback that can give context to the Center's regulatory activities:

  • Patients' experiences living with their specific condition
  • Patients' experiences with devices used for the diagnosis, treatment, or management of their condition
  • Current issues or trends related to medical devices that they use or may be treated with

This information could also provide insights that could be useful in medical device design, clinical studies to evaluate medical devices, and post-market medical device safety monitoring and product refinement.

How Does the Patient and Caregiver Connection Work?

When CDRH staff recognize the importance of patient input in their work at the Center, they can reach out to the Patient and Caregiver Connection. Staff may draft questions for patients, caregivers, or both, and the Partner Organizations in the Patient and Caregiver Connection will disseminate questions or surveys to their membership and collect responses. The Partner Organizations will aggregate the responses and share them with CDRH,assuring no personally identifying information is included.The  feedback obtained will provide broader context and better understanding of the patient experience for CDRH staff to consider throughout the course of their work.

The program is designed to broaden CDRH staff exposure to patients' viewpoints, but not to provide policy advice, recommendations, or opinions.

Who Are the Patient and Caregiver Connection Partner Organizations?

The Partner Organizations listed below align with many medical specialties and reflect broad cross-cutting topics. CDRH anticipates that the breadth of areas covered by the Patient and Caregiver Connection will expand in the future as resources permit, with inclusion of relevant additional partner organizations.