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News From the Food and Drug Administration
November 5, 2019

Enlisting Patients’ Input in Medical Device Trials

JAMA. 2019;322(17):1644. doi:10.1001/jama.2019.17815

The FDA is taking further steps to include a sometimes overlooked voice in the development of medical devices—the patient’s.

In a recently released draft guidance document, the agency suggested a number of ways that device manufacturers can use patients’ perspectives to navigate some of the challenges inherent in designing clinical trials of their products. “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,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.