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FDA Seeks Outside Review of Medical Device Approvals

The Institute of Medicine will study a U.S. Food and Drug administration program that gives fast-track approval to certain medical devices.

Consumer watchdog groups, lawmakers and others have criticized the FDA for using the accelerated approval process for more products than Congress originally intended, leading to problems with devices after they are sold.

Expedited reviews of devices shown to be similar to existing products allow companies to get products to market more quickly and with less expense.

The study of the program by the institute, part of the National Academies, was required by a 2007 law, but the FDA said on Wednesday that the results would not come until March of 2011.


Congressional investigators in January reported that the FDA had allowed numerous products classified as high-risk to be cleared through the expedited process.

More than half of the devices given expedited approval actually used new technology or were intended for a new type of use, the Government Accountability Office found.

Complex devices, which can include heart valves and pacemakers, are meant to receive a more thorough review to determine their safety and effectiveness
Dr. Ned Feder, a staff scientist with the Project On Government Oversight, criticized the study of the FDA process for carrying “no sense of urgency.”

Nevertheless, the study was welcomed by several lawmakers, including House of Representatives Energy and Commerce Committee Chairman Henry Waxman.

“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,” he said.

Janet Trunzo, an executive vice president for the Advanced Medical Technology Association, said the device industry supported the agency’s current “robust” approval process.

“We believe (the study) will underscore the strengths of FDA’s current regulatory approach and dispel many of the misconceptions about the process,” she said.

Announcement of the study follows a shake-up at the agency’s Center for Devices and Radiological Health since President Barack Obama’s choice for FDA Commissioner, Dr. Margaret Hamburg, took over the agency in May.

In August, Dr. Daniel Shultz resigned after leading the device unit for five years.

If you or a family member has been personally injured because of the fault of someone else: by the use of dangerous and defective drugs, bad products, or toxic injury etc then please contact the Dallas Texas Defective Drugs Product Liability Attorney Dr. Shezad Malik. For a no obligation, free case analysis, please call 817-255-4001 or Contact Me Online.

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