Thursday, December 31, 2009

Heart Medical Devices Approved Without Sufficient Scientific Review

medical devices implanted each year in hundreds of thousands of U.S. heart patients often are approved by government regulators based on insufficient scientific review, researchers said.

About two of three cardiovascular devices approved by the U.S. Food and Drug Administration from 2000 to 2007 were tested in a single clinical trial rather than multiple studies....
From Bloomberg's article, "Medical Device Studies Lack Scientific Rigor, Researchers Find" by David Olmos.

The article is a criticism of the FDA, but a more fundamental philosophical question is, what is the proper standard of review for medical devices and drugs?

The review standards determine what medical devices and treatment are approved, experimental and not approved. It also determines the cost incurred and time required by pharmaceutical and medical device companies to get approval for their new medical products. Higher approval costs act as a disincentive, especially for low cost and limited use products.

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