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Independent Testing and the FDA

UCSF
Tue, 03/25/2008 - 22:00
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(UCSF: San Francisco) -- The approval process for medical devices doesn’t involve the same rigorous review used for pharmaceuticals, and to improve health outcomes this needs to change, say researchers from the University of California, San Francisco.

In the January 2008 issue of the Journal of General Internal Medicine, the UCSF team analyzed the problem and concluded that after a device achieves Food and Drug Administration (FDA) approval, a technology assessment by an independent organization can help identify medical devices that are truly beneficial and safe.

The UCSF analysis evaluated the federal review process, the method by which devices come to market, how the scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology’s medical benefit to patients.

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