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The United States has long been the home to cutting-edge innovations in the medical device industry, a remarkable private enterprise success that has improved or extended the lives of millions of people. However, increasingly burdensome regulatory policy is driving pioneering research and development to Europe and to the rest of the world. Nevertheless, the U.S. Food and Drug Administration (FDA) and self-styled public health advocates are engaged in an assault on the primary regulatory pathway through which new products reach the market. This could lead to further erosion of U.S. leadership in this important field.
The primary law governing medical devices, enacted in 1976, established a flexible review process intended to tailor FDA oversight of new and improved devices to a level of regulatory control sufficient to provide a reasonable assurance of safety and effectiveness. Most new devices incorporate fairly modest changes or improvements on previously marketed ones. For that reason, an estimated 90 percent or more of the devices now on the market have been authorized for commercial sales through what is known as the 510(k) process. These products do not go through a full premarket approval, but they are nevertheless subject to numerous and burdensome legal requirements to ensure their safety and effectiveness.
While there have been a few examples of FDA mishandling the 510(k) process by inappropriately clearing devices that should have been subject to full premarket approval, there is no evidence that the 510(k) process itself systematically allows unsafe devices on the market. Nevertheless, the process has been made more strict and more comprehensive over the years through legislative changes and bureaucratic excess. Consequently, many 510(k)-cleared devices must now meet requirements similar to those for devices that go through the full premarket approval process. This has resulted in a lengthier and less predictable review process that hinders innovation.
The FDA recently proposed additional changes that would make the 510(k) review even more onerous, and a report from the Institute of Medicine (IOM) has called for scrapping the 510(k) process altogether. However, most criticisms of the 510(k) process are based on a misunderstanding of how it works and why it was designed the way it was.
The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act created a classification system for devices based largely on the nature of their intended use, the importance of those uses in sustaining or supporting the life or health of patients, and the sufficiency of various regulatory standards in providing a reasonable assurance of safety and effectiveness.
The 1976 Amendments also recognized that most devices would not need to surmount a comprehensive clinical testing and approval process to ensure their safety and effectiveness. Nearly all Class III devices would have to be rigorously tested and pass through the FDA’s stringent premarket approval (PMA) process. And genuinely novel devices that are not substantially equivalent to other devices already on the market are automatically placed into Class III. Devices that contain only minor improvements to a previously marketed Class I or II device must comply with rigorous performance standards and other regulatory controls, but generally do not have to be reviewed through the comprehensive PMA process.
With that classification system in mind, the 510(k) review was designed to ensure that new products were assigned to the correct class. It was not intended to establish an independent safety or efficacy review process akin to premarket approval because the regulatory controls associated with the classification system itself are sufficient to provide a reasonable assurance of safety and effectiveness.
Many observers mistakenly equate the device classes with a measure of risk. However, the classification system is not based on the inherent riskiness posed by the devices, but on their complexity and function. Even for a Class III device, the FDA confirms by approving the PMA application that the product does not pose a “high risk,” but in fact is reasonably safe and effective for its intended use.
Although most Class I devices are exempt from the 510(k) clearance requirement, essentially all Class II devices may not be marketed until the manufacturer submits a 510(k) notification providing a substantial amount of data from laboratory testing, bench trials, and comparative studies demonstrating substantial equivalence to a predicate device before they may be marketed. Clinical testing is not explicitly required by the statute, but the FDA has broad authority to demand clinical data before clearing a Class II device.
During the past 20 years, the FDA has become more aggressive in using this authority, and it has required more and more devices to go through the full PMA process. This has drawn out both 510(k) and PMA review times and has created an atmosphere of unpredictability and uncertainty about what will be necessary to get products to market. Yet, critics have increasingly called for even more legislative and regulatory burdens.
Much of the criticism has focused on a seemingly high number of medical device recalls. From 2005 through 2009, device manufacturers initiated a total of 3,510 recalls for products in all three classes. Without any further context, that number may seem to suggest deep flaws in the regulatory process. But it is essential to examine the data more closely and place those figures in the appropriate context.
In most cases, recalls involve manufacturing or packaging problems that occur after the FDA cleared or approved the device. And, in any event, many recalls involve technical violations of statutory or regulatory requirements that do not affect the safety or effectiveness of the devices in question. Of the recalls issued from 2005 to 2009, the FDA concluded that approximately 96 percent involved little or no risk of harm to patients. Only 131 recalls were considered “high-risk.” Yet even among these, more than half involved infractions such as labeling errors, inadequate instructions, or manufacturing glitches that could not have been prevented by a more thorough FDA review. Roughly 87 percent of those high-risk recalls were of devices cleared through the 510(k) process. But the FDA cleared approximately 18,500 devices through the 510(k) process during the five-year study period, and approved just 150 through the PMA process. That means that fully approved devices were more than 30 times more likely to be recalled.
Arguably the most stinging safety criticism that can be made against the FDA is not that the 510(k) clearance process is flawed per se, but that the agency has mismanaged it by occasionally clearing devices that were not in fact substantially equivalent to predicate devices. Over the past decade, the FDA’s response to the increased public scrutiny over such mishaps has been to add new and more burdensome laboratory and clinical data requirements, and to repeatedly request additional information from manufacturers during the 510(k) review. That response represents yet another form of FDA mismanagement.
In 2009, the FDA commissioned a study by the Institute of Medicine to investigate whether the 510(k) process sufficiently protect patients and promotes innovation, and to recommend changes that would help the agency better achieve those goals. Strangely, the IOM report, published in July 2011, acknowledges that its committee found no reason to believe that any devices on the market are unsafe or ineffective, but it still concluded that the 510(k) process should be scrapped.
Based on 35 years of practical experience with the 1976 Amendments, the IOM could easily have concluded that the 510(k) clearance process has been sufficient to protect patients. Rather than scrapping the entire process, a more effective approach to protecting consumers and promoting innovation is for Congress to engage in more vigorous oversight and investigation of the FDA’s performance.