FDA seeking outside review of device approvals
medical devices program

The U. S. Food and Drug Administration (FDA) has sought a review of its fast-track approval to medical devices program to be reviewed by the Institute of Medicine.

FDA has been condemned for accelerating the approval process for more products than was intended by the Congress which led to problems with devices after being sold.

Companies get the benefit of launching their devices faster and at lower expenses with the fast-track reviews by the FDA when they claim that their product is similar to an already existing device in the market.

The study of the review by the institute was required by a law in 2007 but the FDA said that it can't be done till 2011 March.

Investigators had reported early this year that the FDA has been exercising the expedited process of reviewing products which could be classified as high-risk.

The decision to carry out a study was welcomed by several lawmakers like House of Representatives Energy and Commerce Committee Chairman Henry Waxman, who said, "I have long been concerned that the... process permits too many devices on the market about whose safety and effectiveness even the FDA is uncertain".

On the other hand, Janet Trunzo, an executive vice president for the Advanced Medical Technology Association, said that the present system of approval by the FDA is supported by the device industry.

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