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At Senate hearing, critics slam FDA's device safety record

by Brendon Nafziger, DOTmed News Associate Editor | April 14, 2011

The artificial implantable hip Korgaokar received was cleared by the so-called "fast-track," 510(k) process, where the manufacturer only has to show the device resembles products currently on the market; generally, companies are not required to submit data from clinical trials.

The process has drawn considerable controversy and is undergoing an Institute of Medicine review, the results of which are expected later this year. Last year, the FDA proposed scores of reforms to the process.

"Americans are dying because [devices] aren't being tested," said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington, D.C.-based think tank. "I believe if a device can kill you, it's not a low-risk device...I'm not talking about lightning striking out of the blue, I'm talking about an implant disintegrating in the human body."

In fact, implantable hips fall among the 26 higher-risk device types currently cleared through the 510(k) process, but which the GAO faulted the FDA for not bumping up to a more stringent risk category or putting under review, as the GAO requested in a 2009 report. The GAO said the 1976 legislation, which created the modern device risk categories, intended for high-risk devices to require premarket approval, which generally involves clinical trials.

"But 30 years later, the FDA had still not completed the regulatory steps necessary," Marcia Crosse, a health care policy adviser with the GAO, said.

In her testimony, Crosse also complained about the FDA's postmarket surveillance, saying her agency found that firms initiated 700 recalls per year, but that the GAO "identified gaps in FDA's process that could allow defective products to continue to be used despite recalls."

According to the GAO, two-thirds of devices are exempt from any sort of premarket review. Of the one-third reviewed by the FDA, 90 percent are cleared through the 510(k) process.

FDA's representative at the hearing acknowledged that it was a "strained agency," facing increasingly complex device submissions with limited funds and manpower, but said it was aiming to reclassify or review all the outstanding 26 device categories by the end of 2012.

"[We're] getting information on these remaining device types," said Dr. William Maisel, the chief scientist with the FDA's Center for Devices and Radiological Health.

Maisel also said the agency was working on improving recall and adverse event reporting, and had high hopes for the eventual electronic surveillance of devices.

"There are unique issues with devices that are different than drugs," he said. "Sometimes [it's] difficult to know if an adverse event is due to the device or the surgical procedure to implant the device."

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