Medical Device Review System Called Into Question

An advisory group offered criticism of the Food and Drug Administration's review system for medical devices. But the FDA's reaction appears dismissive.

The Associated Press/Seattle Times: Medical-Device Review System Doesn't Do Its Job, FDA Told
Federal health regulators asked the country's leading medical experts two years ago to recommend ways to improve the government's system for approving most medical devices, ranging from pacemakers to X-ray scanners. On Friday the experts came back with a surprise answer: scrap it because it fails to protect patients. Even more surprising, the Food and Drug Administration (FDA) dismissed the idea (Perrone, 7/29).

Reuters: FDA Balks At Medical Device Shakeup
An advisory group said the U.S. fast-track approval process for medical devices is fatally flawed and should be replaced, but the Food and Drug Administration said the recommendation was a non-starter. The FDA had asked for the Institute of Medicine report as part of a broad agency review of its device unit, an area dogged by high staff turnover, funding woes and major recalls in recent years of devices ranging from artificial hips to heart defibrillators. But the finding was swiftly rejected by the FDA's top device official. "FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement (Seaman, 7/29). 

NPR's SHOTS blog: Panel: FDA Needs A Reboot On Regulation Of Medical Devices
[T]he system the Food and Drug Administration uses to evaluate a big swath of medical devices before they're offered for sale doesn't make much sense, according to a report just released by the independent Institute of Medicine. ... The report, requested by the FDA in the wake of some high-profile device problems a few years back, concludes that a key part of the process is flawed because of the law underpinning it. And the IOM panel recommends that the agency figure out a whole new way of doing things rather than tweaking the current approach (Hensley, 7/29).