FDAnews Device Daily Bulletin

Califf Sees Big Data, Patient Participation Playing Bigger Roles in Device Assessment

Sept. 29, 2016

Patients will play a bigger role in device assessments, and more data will come directly from patients in the future, FDA Commissioner Robert Califf told devicemakers.

“As a clinical investigator, I was always limited because of the amount of data you had to collect,” he said. But now, patients are wearing devices that could provide continuous information. “The secretive clinical world needs to wake up,” he said during the Medical Device Innovation Forum.

The FDA and the Centers for Medicare & Medicaid Services are interested in getting the best technology to patients earlier, he said, so there is a real need to create an ecosystem where quality systems and self-governance are built in. — Tamra Sami

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