Patients are experts in their conditions and offer valuable information to the U.S. Food and Drug Administration (FDA) about living with the condition and its treatments. Patient input can significantly impact the development, evaluation, and monitoring of medical devices.

Discover how the FDA’s Center for Devices and Radiological Health (CDRH) puts patients first with its Patient Science and Engagement Program.

Communicating About COVID-19 Testing to Underrepresented Populations

CDRH and the PATIENTS Program at the University of Maryland Center of Excellence in Regulatory Science (CERSI) are conducting a qualitative study to better understand underrepresented populations’ attitudes towards COVID-19 testing and their willingness to share these data in national information banks.

Underrepresented populations in the study include African Americans, individuals whose primary language is Spanish, older adults, people with lower literacy, people with chronic conditions, and asymptomatic individuals with a household member who has tested positive for COVID-19. Read more

Gender Differences for Heart Failure Patient-Reported Outcome Measure

Cardiovascular disease is the number one cause of death for women in the world. CDRH is partnering with Duke Clinical Research Institute and the Yale-Mayo CERSI on a study to better understand if there are differences in gender responses to a heart failure patient-reported outcome measure. The research team is using a method to evaluate differences in the measure that could be used as a model to understand potential response differences between genders in other patient-reported outcome measures. Read more

Ranking Factors that Influence Women’s Decision Making Regarding Surgical Treatment for Uterine Fibroids

"Patients are the experts in living with their disease or condition. The FDA believes strongly that understanding patients’ unique perspectives and preferences remain a critical aspect to effective medical device development and evaluation.” –Dr. Jeff Shuren, CDRH Director

Patients may see risks or benefits of a device or treatment differently than the physicians or regulators responsible for determining whether a new device can be marketed. CDRH is conducting a patient preference study to better understand women’s preferences for factors that are most important to them as they consider surgical treatment options for uterine fibroids. The goal of the study is to incorporate women’s preferences in the device evaluation process for uterine fibroid treatment. Read more about Patient Preference Information in Medical Device Decision-Making

CDRH will host a virtual meeting on Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices on Tuesday, May 4, 2021.

Industry, patient organizations, researchers, health care professionals, and other interested stakeholders are invited to join this discussion on Patient-Generated Health Data and its use across the healthcare ecosystem and during medical device development, evaluation, and monitoring. Register to view the webcast