IOM Recommends the FDA Dump its 510(k) Process

The U.S. Food and Drug Administration’s (FDA) pre-market approval process does not reliably evaluate device safety and effectiveness and should be scrapped, the Institute of Medicine (IOM) recommended in its long-awaited assessment of the 510(k) program.

Capping 16 months of work, an IOM committee chaired by David R. Challoner, vice president for health affairs emeritus at the University of Florida in Gainesville, released its report on July 29, titled “Medical Devices and the Public’s Health: The FDA’s 510(k) Clearance Process at 35 Years.” The 246-page analysis concludes that the 510(k) approval process is inherently flawed and cannot be salvaged.

The IOM’s report noted that the 510(k) clearance process—used by manufacturers to clear about 90 percent of medical devices for the U.S. market since its inception 35 years ago—“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.”
Translation: data regarding the safety and effectiveness of previously cleared devices is insufficient—therefore, while previously cleared devices might be deemed similar to newer products, they offer no clues about the new products’ safety and effectiveness.

Challoner’s panel urged the FDA to design a new method for assessing moderate-risk devices, possibly one that is based on a modified version of the current “de novo” review process.

“A move away from the 510(k) clearance process should occur as soon as reasonably possible,” IOM wrote in its report. However, during a webcast briefing on the IOM report and recommendations, other members of the panel acknowledged that logistics would prevent the agency from shuttering the program immediately. “We do not believe that one has to shut down the 510k system tonight,” noted William W. Vodra, a retired senior counsel with Arnold & Porter LLP in Washington, D.C. “It is working adequately in the short term. The fundamental problem [with the 510(k) process] is that it is asking the wrong question.”

Rather than modify or change the way it reviews new medical devices, the IOM believes the FDA should develop a more robust “integrated premarket and post-market regulatory framework.”

Though it did not provide the FDA with ideas for a new product review process, the IOM committee did offer some parameters for a recreated premarket and post-market regulatory framework. According to the report, that framework should:

• be based on sound science;
• be clear, predictable, straightforward and fair;
• be self-sustaining and self-improving;
• facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
• give regulatory standards longevity to achieve safety and effectiveness; and
• be risk-based.

While it believes the 510(k) process is flawed, the IOM committee noted that most medical devices cleared through the pathway have been “reasonably effective.” The committee, however, could not come to such a conclusion about the impact of the 510(k) process on innovation (much to the disappointment of industry experts, who long have argued that the 510(k) clearance process has historically been a safe and effective way to introduce new and innovative products.

Besides jettisoning the 510(k) process, the IOM report also made several other notable recommendations, including:

• The FDA develop and implement a comprehensive strategy to collect, analyze and act on medical device postmarket performance evaluation;
• The FDA review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed;
• The FDA commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the device industry; and
• The FDA develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices and software used as a tool in producing devices.

The IOM panel also berated the FDA for foot dragging. “After 35 years, the FDA has not completed the task of calling for PMAs [premarket approvals] for or reclassifying preamendment Class III device types,” the panel said. “Congress in 1990 directed the FDA to complete this task in a timely manner.”

The committee’s recommendations—particularly its suggestion that the FDA ditch the 510(k) process and start from scratch—did not sit well with the agency. In a statement released before the IOM’s webcast briefing, Jeffrey Shuren, director of the Center for Devices and Radiological Health, argued that “any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.” He also said the FDA disagrees with the IOM’s suggestion to scrap the 510(k) program, though he added that the agency is “open to additional proposals and approaches for continued improvement” of its device review programs.

Comments by FDA Commissioner Margaret Hamburg appeared to echo Shuren’s sentiments. During a July 28 hearing of the U.S. Senate’s Health, Education and Labor Pensions Committee (the day before the report was released), Hamburg said, “We will welcome the IOM report and its recommendations, but they are just recommendations. We will review them internally and engage with stakeholders to get their perspectives on the recommendations.”

The FDA has internally been reviewing the 510(k) process for more than a year. In January, the agency released a 25-step plan to overhaul the process, and this week, issued its first draft guidance on the times that changes to a medical device may require a new submission.

The FDA noted that the design of a new regulatory framework for Class II devices may require congressional action.

“Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices,” Shuren said. “These actions, plus a sufficiently funded device review program, will contribute to a stronger program.

The FDA, however, was not the only organization with a less-than enthusiastic reaction to the IOM report. Stephen J. Ubl, president of the Adanced Medical Technology Association (AdvaMed), contends the IOM report should be scrapped itself.

“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” Ubl said in a prepared statement on the organization’s website. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

John Manthei, a global co-chair of Latham & Watkins LLP’s Healthcare and Life Sciences Practice Group, agreed. “I don’t think anyone expected the IOM to go as far as it did in recommending to abandon the 510(k) program,” Manthei told OrthopedicDesign &Technology. “I also don’t think there will be any appetite from industry, FDA, or senior members of Congress to seriously consider that proposal.”

Maybe not, but the FDA is planning a public docket to solicit comments on the report.