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Medical Devices that Don’t Need Strict Safety Testing

November 3, 2011
Colson Hicks Eidson

Are some medical devices such as artificial hips and knee implants getting on the market without strict testing and clinical trials? The answer is “yes” and a federal agency is at the center of it.

An abbreviated Food and Drug Administration (FDA) approval process for medical devices has some experts criticizing the agency for allowing untested and unsafe medical devices on the market. The FDA program is called the 501(k) program, and it allows a new medical device to bypass strict clinical testing if it is “substantially equivalent” to a device already on the market.

So far, artificial hips, knee implants and vaginal mesh implants have reached the market through the 501(k) program. All of the products have injured patients in various ways. An article in the New England Journal of Medicine recommended that the FDA stop the program immediately for Class III devices, which are the highest threat to patients. The article said that quick approval for high-risk devices is inappropriate.

A hearing on Capitol Hill proved futile earlier this year when Florida Congressman Cliff Stearns called increased federal regulation of medical devices burdensome, and that it only stifles innovation.

Are you in favor of medical innovation over patient safety?

Colson Hicks Eidson – Florida injury attorneys