FDA's 510(k) System Should Be Scrapped, IOM Concludes

Reed Miller

July 29, 2011

July 29, 2011 (Washington, DC) — The FDA's 510(k) process for clearing putatively moderate-risk devices has been criticized by some for being too lax and by others for obstructing innovation. Now, a long-awaited report from the Institute of Medicine (IoM) of the National Academies of Science concludes that the 510(k) process can't merely be repaired but ought to be scrapped and replaced by a more reliable system [1].

The FDA needs to replace the current regulatory framework for class II devices "so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle," the IoM committee recommends in its report, released today at the National Academies of Science headquarters in Washington, DC. "It's not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help," committee chair Dr David Challoner (University of Florida, Gainesville) said. "The 510(k) process cannot achieve its stated goals--to promote innovation and make safe, effective devices available to patients in a timely manner--because it is fundamentally at odds with the statutes that govern how FDA must implement the process."

While the FDA might not have enough information now to start designing a new "framework," it can get started "within a reasonable time frame," the report states.

As reported by heartwire , the FDA asked the IoM to produce a comprehensive report on the 510(k) system (formally known as premarket notification) as part of its own review of the system that began in August 2010. Public-interest groups, some FDA staffers, physicians, and members of Congress have long argued that because the 510(k) system only requires that the manufacturer show the new device is "substantially equivalent" to an approved device, it allows too many devices to enter the market without enough clinical data to prove their safety.

Meanwhile, manufacturers and their allies in Congress argue that the FDA's application of the 510(k) rules is inconsistent, not transparent, and one of the FDA processes that must be reformed in order to keep the American medical-device industry competitive, especially because the European device approval system is generally a lot easier to navigate.

Wrong Tool for the Job

"In reviewing the legislative and regulatory history of the 510(k) program, the committee found that it was designed in 1976 to provide only a determination of the substantial equivalence of a new device to an already marketed (predicate) device; it was not designed to determine whether a new device provides a reasonable assurance of safety and effectiveness or whether it promotes innovation," the IoM committee explains in the report.

At odds in the FDA process are the stated goals of the 510(k) process: to make safe, effective devices but also to promote innovation in industry. "The committee struggled with how to address the conflict between the legislative framework of the program and the FDA's stated goals," the report notes.

The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.

Medical devices on the market before the 510(k) process was created by the 1976 Medical Device Amendments were never systematically assessed for safety and effectiveness. Therefore, subsequent 510(k)s based on equivalence to preamendment devices are not necessarily safe and effective.

"The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device," the IoM report concludes. "The committee is not suggesting that all, many, or even any medical devices cleared through the 510(k) clearance process and currently on the market are unsafe or ineffective. Rather, the committee found that the available information is insufficient to support highly confident conclusions about the safety and effectiveness of 510(k)-cleared medical devices in clinical use."

510(k) Is Not Promoting Innovation

The FDA maintains that the 510(k) process should promote technological innovation in addition to ensuring safety and effectiveness, but the IoM committee concluded the current process does very little to encourage manufacturers to innovate.

"At most, promotion of innovation was a byproduct of a process that, by minimizing unnecessary regulatory burdens, facilitated the entry into the market of new devices that do not raise novel questions of safety or effectiveness," the IoM committee concludes. Since the 510(k) process generally requires less time and fewer resources for the manufacturer than the premarket approval (PMA) process for high-risk devices, medical-device makers almost always seek to have their device cleared through the 510(k) process rather than the full PMA process.

The IoM report acknowledges the criticisms from industry and others that the FDA's implementation of the 510(k) program is not transparent and predictable and therefore deters venture-capital investment in future medical-device development. But ease of premarket review and relative speed to market are not surrogates for innovation, the committee concludes, while noting that FDA is "persistently hindered . . . in fully developing these materials by a lack of or limitations in human, fiscal, and technologic resources and capabilities."

The IoM committee also found that some of the regulations and terminology related to 510(k) should be clarified to prevent misunderstandings between FDA reviewers and manufacturers.

Postmarket Monitoring Is Deficient

The IoM report also calls on the FDA to improve the postmarket surveillance of class II devices. In a letter to the director of FDA's Center for Devices and Radiological Health (CDRH), Dr Jeffrey Shuren, the IoM's Challoner chided the FDA for failing to extensively use what he called a "broad array of tools available to address safety concerns in the postmarket period" and to explain why it has not been using them [2].

Again, the report agrees with the FDA leadership that the agency needs more money to do its job. "The FDA's device postmarketing surveillance programs have been adversely affected by the instability of the agency’s congressional financing," the IoM committee concludes.

Non-FDA databases could help the FDA monitor devices already on the market, but so far there has been little collaboration in these efforts among the FDA, healthcare facilities, healthcare providers, the medical-device industry, professional societies, payers, and patient-advocacy groups, according to the IoM committee.

Industry Tries to "Prediscredit" IOM Report

Two days before the release of the IoM report, Barry Meier reported in the New York Times that lawyers for medical-device manufacturers began casting aspersions on the report even before it was released [3]. For example, the Washington Legal Foundation, a probusiness group, petitioned the FDA not to adopt any of the report's recommendations because the panel did not include officials from industry, the investment community, or patients who had benefited from devices but did include a law professor who used to work for Public Citizen, a well-known consumer-advocacy group that has been frequently critical of the FDA and the medical-device industry. However, Meier points out, two lawyers on the IoM committee have worked for the medical-device industry in the past.

The FDA is not legally bound to follow the IoM's advice, but Dr William Maisel, the chief scientist of for CDRH, told Meier that the agency was satisfied with the panel's makeup and "it would be difficult to find a more reputable scientific organization than the Institute of Medicine."

As reported by heartwire , industry advocates and House Republicans have cited industry-sponsored reports as evidence that FDA regulation is slowly strangling the US medical-device industry. At the latest in a series of House Energy & Commerce Committee oversight subcommittee hearings on the topic earlier this month, however, the editors of the Journal of the American Medical Association, the New England Journal of Medicine and the Archives of Internal Medicine questioned the validity and methodology of some of those reports.