Who Are We?
The Patient Science and Engagement Program is a team of social scientists, health economists, statisticians, clinical providers, and other experts committed to engaging with patients as partners and including the patients’ perspectives into medical device development and evaluation.
What Do We Do?
The Patient Science and Engagement Program team leads the Patient Engagement Advisory Committee as well as patient engagement activities focused on medical devices. We also help develop and evaluate tools that measure patient experiences and perspectives which include:
- Clinical outcome assessments
- Patient preference information
- Patient-generated data (such as that collected by consumer wearable devices ).
Patient Science and Engagement Initiatives at CDRH
What Is Our Mission?
The mission of the Patient Science and Engagement Program is to engage with patients, understand their perspectives, and proactively integrate the patients’ perspectives into the total product life cycle of medical devices to help protect and promote public health.
What Is Our Vision?
Our vision is that patients and caregivers in the United States have timely access to high-quality, safe, and effective medical devices that meet their needs and improve their quality of life.
Interacting with patients as partners to advance safe and effective device use over the total product life cycle is part of our daily business and leads to regulatory decisions and actions that consistently place the patient at the center of what we do.
Patient input in the development of clinical studies and the generation of science-based information assures studies evaluate what matters most to patients and that patients have access to useful, understandable information about medical devices that helps to inform their health care decision-making.
Contact the Patient Science and Engagement Program
If you have questions about patient engagement opportunities at CDRH, email CDRH_PatientEngagement@fda.hhs.gov.