Statement from Acting FDA Commissioner Ned Sharpless, M.D., on FDA efforts to encourage patient engagement in medical device clinical investigations

https://www.fda.gov/news-events/press-announcements/statement-fda-efforts-encourage-patient-engagement-medical-device-clinical-investigations?utm_campaign=092319_Statement_Efforts%20to%20encourage%20patient%20engagement%20in%20medical%20device%20clinical%20investigations&utm_medium=email&utm_source=Eloqua

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on FDA efforts to encourage patient engagement in medical device clinical investigations

At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications. We value patient experience and insights about living with a disease, like diabetes or end-stage renal disease, as well as any impact a medical device—such as a glucose monitor or hemodialysis system—has had in a patient’s diagnosis, treatment and management of that disease. Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate. How medical devices are tested to determine a favorable benefit/risk profile is at the core of our medical device evaluations, and the patient voice provides important value in that process. Typically, medical device developers work with health care providers, clinical researchers and the FDA to design and test medical devices to understand how the product will benefit patients, but the process often does not incorporate direct input from patients. Without patient input in the design and conduct of the clinical investigation, outcomes important to patients may not be captured, clinical visits may become overly burdensome and study enrollment could be negatively impacted. This can lead to increased time to ...

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