Report sparks controversy over FDA medical device review system

By Molly Merrill
09:30 AM

The Food and Drug Administration medical device review system is coming under fire, after a report found most medical devices that have been recently recalled were initially approved through an expedited process or were exempt from regulatory review.

The report was published online in the Archives of Internal Medicine.

"Unlike prescription drugs, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) using two alternative regulatory standards: (1) premarket approval, which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device)," write the authors of the report. "The second standard is intended for devices that the FDA deems to involve low or moderate risk."

In January the FDA announced plans to to improve the 510(k) program and make it safer.

[See also: FDA's 25 action plan for 510(k) process aimed at boosting patient safety.]

"The 510(k) reform implementation plan recently announced by the FDA provides for improving reviewer and manager training, establishing a Center Science Council to ensure consistency in the review process, issuing more guidance documents to provide greater clarity to manufacturers, and applying additional requirements on a targeted basis," says Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed). "This is the right way to improve a process that has a demonstrated safety record for more than 30 years and is fundamentally sound."

Ubl is calling the report "seriously flawed and inconsistent with three previous analyses of the same data set conducted by respected researchers."

Diana M. Zuckerman, PhD, of the National Research Center for Women & Families in Washington, D.C., and colleagues analyzed the FDA's list of high-risk device recalls from 2005 to 2009. Using FDA data, the authors determined whether recalled devices were approved by the more rigorous premarket approval process, the less stringent 510(k) process or were exempt from FDA review.

Between 2005 and 2009, 113 devices were recalled because the FDA determined those devices could cause serious health problems or death. Of these, 21 (19 percent) had been approved through the premarket approval process, 80 (71 percent) were approved through the 510(k) process and eight (7 percent) were exempt from regulation.

"Of the recalled devices cleared for market through the 510(k) process, 12 percent were marketed for risky or life-sustaining Class III indications, which are required by law to undergo a full premarket approval regulatory review," the authors write.

The high-risk recalls included devices with a broad range of clinical applications, but the most common were cardiovascular devices (31 percent). Of these, two-thirds (23, or 66 percent) were approved using the expedited 510(k) process and 12 (34 percent) were cleared through the postmarket approval process.

"The FDA's implementation of the 510(k) process has received considerable criticism from public health advocates and from other federal agencies in reports, medical journal articles and testimony before Congress," write the authors. U.S. courts have also recognized the shortcomings of the expedited process. However, the relatively small division of the FDA charged with device approvals does not receive sufficient funding from Congress to conduct premarket approval on every device, the authors note.

"When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than three out of four of the high-risk recalls during the last five years," they conclude. "Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."

[See also: IOM study to identify 'productive path' for using HIT to boost patient safety]

Ubl disagrees. "Because of an elementary error in data analysis, the conclusions drawn from the study are faulty, and the paper is marked by a large number of factual errors and misleading inferences. Adoption of the paper's recommendations would actually harm American patients by further delaying access to safe and effective treatments," he says.

Ubl notes that "three recent studies have all found that the 510(k) process has a remarkable safety record with extremely low recall rates–one study reported a rate of less than two-tenths of one percent."

"A real concern at FDA, however, is the growing lack of predictability and consistency in product reviews, needlessly delaying patient access to safe and effective diagnostics and treatments," he says. "Today, foreign patients benefit from new treatments two to three years sooner than American patients, even when those treatments are invented and manufactured right here in America. The last thing patients need is more red tape and bureaucracy that do not contribute to safety."

Click here to read more about AdvaMed's analysis of the report.