FDA Critics Cite Recall Numbers as Evidence That Too Many Devices Are Easily Cleared as 510(k)s

Reed Miller

February 16, 2011

February 16, 2011 (Washington, DC) — Critics of the FDA's medical device premarket review system argue that the past five years of medical-device recall data provide further evidence that the 510(k) clearance process is letting too many devices reach the US market without sufficient premarket review [1]. But the device industry and the agency argue that recall data simply reflect  that most devices go through the 510(k) process rather than the premarket approval (PMA) process, and not that the 510(k) system is too lax.

In an article published online February 14, 2011 in the Archives of Internal Medicine, Dr Diana Zuckerman (National Research Center for Women & Families, Washington, DC) and colleagues analyzed the 113 class I device recalls from 2005 to 2009. Class I recalls are for problems that the FDA believes have a "reasonable chance" of causing serious adverse outcomes or death.

The authors point out that 21 of these recalled devices (19%) had originally been approved by the premarket approval (PMA) process, which requires that the manufacturer demonstrate the device is safe and effective, usually with a major clinical trial. Another 71% of the recalled devices were cleared through the 510(k) premarket notification process, which requires the manufacturer to show that the device is substantially equivalent to an approved device, and 7% of the recalled devices were exempt from FDA premarket review. A plurality of the recalled devices, 31%, were cardiovascular devices, including 23 that originally reached the market through the 510(k) route.

Of the 23 high-risk recalls of 510(k)-cleared cardiovascular device, 13 were automatic external defibrillators (AEDs). Zuckerman et al cited a recent FDA report that found that about 20% of all AEDs on the market have been subject to a recall at some point and that hundreds of people have died due to AED malfunctions. Other cardiovascular devices that were cleared by 510(k) and later subject to a recall include intra-aortic balloon pumps and an extracorporeal blood pump.

Recalls of general hospital devices, such as insulin pumps and intravenous fusion devices, accounted for 24% of the high-risk recalls of 510(k)-cleared devices. Neurology devices, including shunts and devices for repair of the face, jaw, and cranium, represented 5% of the high-risk 510(k)-cleared devices that were eventually subject to recall. Anesthesiology devices accounted for 10%, 9% were clinical chemistry analysis devices, and 20% were simply categorized as "other." Only 3% of the devices were ophthalmic, but this group accounted for the largest number of units, about 57 million.

In written comments on the article by Zuckerman et al, the FDA public affairs office points out that the 80 recalls of 510(k) devices should be "kept in perspective" because they represent of a tiny fraction of 510(k)-cleared devices. Over 19 000 devices were cleared via 510(k) from 2005 to 2009, and a review of recall data presented at the July 2010 Institute of Medicine meeting found that the annual recall rate for all 510(k) devices--high risk and lower risk--is 1% to 1.5% per year. "Over 90% of the devices requiring premarket submission are cleared via the 510(k) pathway; therefore, it is not surprising that the majority of recalled devices are 510(k)."

Nevertheless, Zuckerman et al argue, "Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review. These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices." The authors recommend that the FDA "fully implement" the law that subjects all "life-saving and life-sustaining" (class III) devices to the PMA process, and that definition should account for the risks to patients in cases of device failure. The authors also want the FDA to expand its authority over premarket inspections of manufacturers of 510(k) devices and to strengthen its authority to use special controls for 510(k) devices such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

The FDA and the Institute of Medicine have been reviewing the agency's 510(k) system for over a year, and the agency is also reviewing the classification of the remaining "preamendment" devices. These are devices that existed before the FDA began regulating medical devices and are currently categorized as class III but, unlike most class III devices, can reach the US market through the 510(k) premarket notification process. By December 2012, all of these devices will either be down-classified to class II and continue to be subject to the 510(k) process or kept in class III and subject to a PMA from now on, the FDA says. Recently, an FDA advisory panel recommended that one such device group, AEDs, be placed in class III and subject to the PMA process.

In correspondence with heartwire , coauthor Dr Steven Nissen (Cleveland Clinic, OH)pointed out that Federal Regulations Title 21, part 860, states that the 510(k) process should not be used for class III devices because, by law, devices that "support or sustain life" must undergo PMA evaluation. Therefore, no 510(k)-approved device should need to be withdrawn for the likelihood of "causing serious injury or death," Nissen said.

In an editorial accompanying Zuckerman et al's paper [2], Archives of Internal Medicine editor Dr Rita Redberg (University of California, San Francisco) reiterates her plea for the FDA to reform the 510(k) process to ensure devices are not reaching the market without adequate clinical testing or oversight. "Implementation of the FDA's 510(k) plan is an opportunity to immediately strengthen device safety regulations to protect Americans from avoidable injuries and death," she argues. "This process must begin by appropriately classifying high-risk devices according to their risk for adverse events and by requiring high-quality clinical data of safety and effectiveness so that the FDA will get it right the first time."

In a "fact sheet" intended to rebut the paper by Zuckerman et al, AdvaMed, the trade group that represents the medical device industry's interests in Washington, says the analysis by Zuckerman et al "is seriously flawed" and inconsistent with previous analysis of the same data by other researchers [3]. "The conclusions drawn from the study are faulty," according to AdvaMed.

The industry lobbyists are most critical of the paper's comparison of the  absolute number of class I recalls for 510(k) products with the absolute number of recalls for PMA products from 2005 to 2009, without also pointing out that 510(k)s are far more plentiful than PMAs. About 99% of devices are cleared through the 510(k) process, but only 71% of recalls were for 510(k) products, AdvaMed points out. "To conclude that the safety profile of the 510(k) process is inferior because a larger number of 510(k) products are recalled is like concluding that the United States' system of cancer care is inferior to Monaco's because more people die of cancer in the US each year than in Monaco, without considering the population differences."

The trade group also cites other studies of the recall rate for 510(k) products that have shown "a very low class I recall rate." For example, a study by the Battelle Memorial Institute, a private nonprofit science and technology development corporation in Columbus, OH,found that the recall rate for all 510(k) products was <0.2% and that the recalls that could conceivably have been caught in the premarket review process was <0.1%.

"The claim that withdrawal rates are 'low' is specious," Nissen told heartwire . "If you boarded an airplane and the pilot told you there was a 99% chance the plane would take off and land safely, would you disembark or fly?" He points out that there were 113 devices for a total of 112.6 million individual units subject to class I recalls, and in 2006 alone, there were 2830 device-related deaths reported to the FDA and 116 000serious injuries. "I would not call that an 'extremely low' rate."

The industry group also takes exception to Zuckerman et al's characterization of the 510(k) process as "not requiring clinical trials or manufacturing inspections." While it conceded that the FDA requires clinical trials for about only 10% to 15% of 510(k) devices, the agency already has the authority to require any data it believes is "necessary to clear the device," AdvaMed maintains. The agency also has the authority to inspect any manufacturing plant at any time and can conduct a preclearance inspection of the manufacturer of a 510(k) if necessary, although it usually chooses not to.