Patients provide valuable input to the FDA in a variety of forms. Gathering input and perspectives from patients is useful for better understanding the disease or condition and its impact on patients, identifying outcomes most important to patients, and understanding benefit-risk trade-offs for treatment.
The FDA recognizes that while “scientists, clinicians, device developers, and regulators play critical roles in evaluating and communicating the benefits and risks of medical devices...only patients live with their medical conditions and make daily choices regarding their health care. Their voice and perspective are critical to understanding the impact of medical devices.” The FDA's Center for Devices and Radiological Health (CDRH) utilizes an approach known as patient preference information that “captures the value that patients place on aspects of the medical device in a way that accounts for differing patient perspectives on benefits and risks that come with using that device or treating the condition.”
To learn more about how Patient Preference Information helps CDRH understand medical device risks and benefits, visit the FDA's Patient Preference Information website here.