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Quality / Medical Devices / Regulatory Affairs / Research and Development

Patient Engagement Continues to Grow, Despite Difficulties

Dec. 14, 2017

The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the summit.

As part of a shift by the FDA to patient-centered care that began in 2011, the agency set a goal of increasing its engagement with patients and it is now 96 percent patient-engaged, according to CDRH Director Jeff Shuren.

Today, an increasing number of devices are being commercially distributed in the U.S. that were designed with patient input, as well as clinical trials that included patient-reported health outcomes. The percentage of FDA-approved clinical trials that include patient-reported health outcomes has now reached 80 percent, Shuren said.

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