FDA considers revising medical device approval process

The Food and Drug Administration (FDA) is considering changing the 510(k), accelerated device approval process, which currently provides medical device manufacturers a “fast track” in obtaining FDA approval to bring a new device to market after an Institute of Medicine Report (IOM) made the recommendation.

Currently, medical device manufacturers are able to issue a Premarket Notification which claims that a new medical device is “substantially equivalent” in design, material, intended use and manufacturing than an existing device, then the device is cleared to come to market without lengthy testing.

The 510(k) process has come under fire from consumer groups after devices like the DePuy ASR XL hip implant system had a high failure rate. Many feels that the 510(k) process has brought defective devices to market without adequately testing them, putting patient’s health at risk.

In the case of the DePuy hip implant, the implants shed metal in some patients when the metal-on-metal components rubbed against each other causing a serious condition called metallosis. Patients also had other complications including fractures and severe pain.

The DePuy hip implants are not the only devices that have used a fast pass through the system. Other products including pacemakers, stents, bandages and artificial knees have also used the 510(k) approval process which substantially reduces costs for the manufacturer.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We are a personal injury law firm and we represent the product liability claims of people who have been injured due to defective medical devices.

Related Posts:

DePuy hip implant recall shows the need for National Joint Registry in the U.S.

U.S. Senate hears testimony from patient with defective DePuy hip implant

Congress and FDA discussing medical device review process

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