Statement from Acting Commissioner of Food and Drugs 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.
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