July 29th, 2011

Controversial IOM Report Highly Critical of 510(k) Process

The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The IOM said the current process is unable to provide “a reliable premarket screen of the safety and effectiveness” of these devices.

The FDA’s director of the Center for Devices and Radiological Health said in a press release that “the 510(k) process should not be eliminated” but also said that the FDA was “open to additional proposals and approaches for continued improvement of our device review programs.” The IOM report had originally been commissioned by the FDA.

As reported earlier this week in the New York Times, the IOM report was the subject of a preemptive attack by the medical device industry before the report was even released. AdvaMed, the medical device industry association, released a statement rejecting the conclusions of the report, saying they “do not deserve serious consideration.”

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