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Medical Devices / Regulatory Affairs

FDA to Leverage Patient-Generated Data for Medical Devices

Dec. 6, 2018
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Nearly half of clinical trials for medical devices fail to reach their enrollment goals and the FDA wants to know why.

The FDA’s Patient Engagement Advisory Committee (PEAC) met in mid-November to discuss new ways of getting patients not just enrolled in device trials, but active in helping to shape them.

Last week, the agency released a PEAC discussion document for stakeholder comment on patient engagement in trials and said trials designed with patient input may be “more likely to enroll and retain patients, collect information meaningful to patients and other key stakeholders, and be successfully completed.”

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