The agency's "Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations" draft guidance proposes recommendations for various aspects of design for clinical trials of medical devices. The agency wants to garner direct input from patients as part of the medical device testing process that determines a benefit-risk profile for devices. Comments on the draft guidance will be accepted through November 22.
In a statement, FDA Acting Commissioner Dr. Ned Sharpless noted that the agency values patient experiences with glucose monitors and other devices in the diagnosis and management of common, chronic diseases such as diabetes and end-stage renal 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," he said.
Often, medical device developers collaborate with healthcare providers, clinical researchers, and the FDA to design and test medical devices to understand how products will benefit patients. However, the process usually does not gather input directly from patients, according to Sharpless.
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