29.07.2011

FDA to assess contact lens device approval

FDA to assess contact lens device approval

Posted by Martin Burns

The way in which the US Food and Drug Administration (FDA) approves the devices used to make contact lenses is set to be overhauled for the first time in decades, it has been revealed.

The FDA is to change its review process as an Institute of Medicine panel has deemed that the way in which many medical devices are approved may not be fully considering patient safety.

According to the institute, there needs to be a significant reworking of how the US government regulates medical devices, which is a $350 billion (£213 billion) industry including hundreds of applications.

The FDA's device director, Jeffrey Shuren, commented: "[The] FDA believes that the 510(k) process [which grants speedy approval] should not be eliminated but we are open to additional proposals and approaches."

However, David Challoner, former vice-president of health affairs at the University of Florida, told the Associated Press: "We need something different. We're dealing with a whole new world: new technology, new materials and new data."

by Martin Burns


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