Device Approval Review Includes Payments to Clinical Trial Sites

Sponsor payments to clinical trial sites may soon become part of the public record in FDA reviews of applications for device premarket approval, Mark Melkerson, director of the Division of Surgical, Orthopedic and Restorative Devices at CDRH, said at a meeting of the Orthopedic and Rehabilitation Devices Panel this month. The panel discussed Zimmer Spine’s Dynesys spinal system trial where half of the patients were treated at medical centers that reported more than $100,000 in payments from the company, according to agency briefing papers.
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