Posted by Michael Wonder on 23 Sep 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
23 September 2019 - At the U.S. FDA 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 haemodialysis 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.
