GAO Weighs in on 510(k), Device Safety Debate During Capitol Hill Hearing

According to investigators at the Government Accountability Office (GAO), the U.S. Food and Drug Administration (FDA) is putting patients at risk with its current 510(k) program.

The GAO caims too many devices are approved through the 510(k) route–which is a track for less-risky or “me too” devices already on the market—instead of the premarket approval process reserved for novel or more complex technology.

It’s the “me too” part of the 510(k) process that concerns many. According to current regulations, high-risk devices that were already on the market in 1976 (when the medical device classification system began), such as certain types of defibrillators and orthopedic implants can go through the faster 510(k) system if manufacturers could show they are “substantially equivalent” to their precursors. In 1990, Congress ordered the FDA to end the practice, but it has continued. According to the FDA, at present, only 10 percent of 510(k)-cleared devices require clinical data for approval.

The U.S. Senate’s Committee on Aging, held a hearing on April 14 examining the FDA’s role in protecting patient safety as part of the medical device approval process. The panel featured testimony from Marcia Crosse, Ph.D., director of the healthcare team at the GAO. Crosse’s testimony outlined the preliminary findings of an ongoing GAO investigation into the FDA’s management of medical device review, postmarket monitoring and recall processes.

“Concerns persist about the effectiveness of the 510(k) process in general, including its ability to provide adequate assurance that devices are safe and effective,” Crosse said in her testimony. “Gaps in FDA’s postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled.”

The GAO previously faulted the FDA in a 2009 for not reclassifying more than 26 types of devices so they receive more stringent reviews. Since then, the agency has cleared 67 individual, high-risk devices through the 510(k) system.

The FDA has faced complaints from medical device manufacturers that the speed of U.S. device reviews lag behind other countries. At the same time, public safety advocates point to reports by GAO and others that suggest the agency is being too lenient in clearing critical devices that keep patients alive.

William Maisel, M.D., deputy director for science in FDA’s Center for Devices and Radiological Health, told lawmakers that the FDA would reclassify the 26 types of high-risk devices cited by GAO before the end of 2012.

“FDA evaluates thousands of medical devices annually and the vast majority of these devices perform well and improve patient health,” Maisel’s said in prepared testimony.

According to GAO, the FDA has reclassified only one group of devices since 2009, leaving 26 remaining.

The medical device industry is concerned that these management problems have slowed medical device innovation. In his testimony, David Nexon, senior executive vice president of the Advanced Medical Technology Association (AdvaMed) industry trade group, said that there are, “inefficiencies at FDA that delay patient access to new treatments and cures and erode U.S. global competitiveness in the development of medical technology.”

The hearing highlighted the story of Katie Korgaokar, a Denver, Colo., resident who received the ASR hip implant manufactured by Johnson & Johnson’s DePuy orthopedic division, to treat a congenital condition called Perthes disease. In 2010, the DePuy hip was recalled and Korgaokar endured a second hip-replacement surgery in early 2011. Korgaokar was one of 96,000 patients affected by the DePuy hip recall. DePuy has come under fire recently from the number of recalls related to its metal-on-metal ASR system.

A recent study, led by Diana Zuckerman, Ph.D. and published in the Archives of Internal Medicine, found that from 2005 through 2009, the 113 highest-risk device recalls involved 112.6 million recalled products. Zuckerman testified at the hearing that, “In the first six months of 2010, the FDA recalled more than 437 million additional products because of high risks, including death … in just six months there were 1.4 medical devices recalled for every person living in the U.S.”

Sen. Herb Kohl (D-Wis.), chairman of the committee, said he would be advocating for further reforms at the FDA and urged Maisel to push forward with an effort to classify high-risk devices now defaulting through the agency’s “fast track” approval system.

“I am encouraged by the numerous initiatives that FDA is implementing for more effective medical device approval and post-market surveillance,” Kohl said. “Nevertheless, I’m concerned that the agency’s oversight of medical products still remains on the GAO’s ‘high risk’ list … and that is unacceptable. FDA has had over 20 years to tackle these high risk devices,” Kohl said. “As we have seen with the Johnson & Johnson hip implant today, it’s high time to protect patient safety and correctly classify these devices.”

Kohl also suggested that FDA develop a “more robust post-market surveillance program” signaling his interest in addressing this concern in the Medical Device User Fee and Modernization Act reauthorization next year.