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"SAFETY ONLY" DEVICE EVALUATION INCONSISTENT WITH COST- CONTAINMENT

This article was originally published in The Gray Sheet

Executive Summary

"SAFETY ONLY" DEVICE EVALUATION INCONSISTENT WITH COST- CONTAINMENT trends in the medical care industry, FDA says in a recent background document responding to calls for the Center for Devices and Radiological Health to regulate only the safety, and not the effectiveness, of medical devices. "In an era of increasing emphasis on cost-containment," FDA contends, a "safety only" device evaluation system "would waste money by subjecting patients to ineffective treatments before the 'medical marketplace' weeded them out." FDA released the backgrounder in response to an Aug. 12 report on the ABC News television program "20/20" that was highly critical of CDRH's approval policies.

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