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IOM Report Urges FDA Shift from 510(k) Program

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) –The Institute of Medicine today proposed that the US Food and Drug Administration effectively scrap its 35 year-old 510(k) medical devices clearance program in favor of a hybrid model that would mix pre-market and post-market review activities in order to better protect consumers and promote innovation.

The report IOM presented today in a press briefing in Washington, DC, the product of an 18-month study that was commissioned by the FDA, includes recommendations that would result in a new system for regulating and handling Class II devices, which covers in vitro diagnostic (IVD) and multiplex diagnostic testing.

"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," David Challoner, chair of the Committee on the Public Health Effectiveness of the FDA 510(k) Process, said in a statement today.

"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 they are fundamentally at odds with the statutes that govern how FDA must implement the process," added Challoner, who is emeritus vice president for health affairs, University of Florida, Gainesville.

In a press briefing today Challoner said the committee "recognizes that we are suggesting a paradigm shift that is likely to be disquieting to a variety of constituencies."

A key critique the committee had with the 510(k) process is that it bases its decisions in large part on whether or not a device has 'substantial equivalence' to any previously cleared device, and not on data about safety and effectiveness, the report claimed.

Although it commissioned the committee's research and report, FDA today issued a statement defending the track record of the 510(k) program and explaining that it is already undergoing internal transformations aimed at correcting some of its shortcomings.

"Medical devices in the US have a strong track record of safety and effectiveness," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the FDA statement. "The 510(k) program has helped support a robust medical device industry in the US and has helped bring lower-risk devices to market for the patients who need them.

"FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.

FDA also said that it plans to open a docket to receive public comments on the IOM report, "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years."

The Advanced Medical Technology Association, a medical device industry trade group, struck a sharper note in its response to the IOM recommendations.

"The report's conclusions do not deserve serious consideration from the Congress or the Administration," AdvaMed President and CEO Stephen Ubl said in a statement. "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."

The IOM committee said that it found that there is not enough information available or being tracked to know the extent to which the 510(k) clearance process is either facilitating or inhibiting innovation. To that end, the committee recommended that FDA begin gathering information that would help inform the design of a new framework to replace the current one and would integrate premarket and post-market regulations. Once the necessary information is gathered, the IOM report stated, Congress should enact legislation to create this new regulatory framework.

"Numerous academic studies have shown that the 510(k) process is overwhelmingly safe," Ubl said. "The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance."

Shuren said today that ongoing FDA reform programs could satisfy some of IOM's concerns about the 510(k) process.

"Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program," said Shuren. "Any major modifications made to the agency's premarket review programs should be based on sound science and through thoughtful and transparent discussion."

FDA undertook its reform program in September 2009 to assess what changes should be made in the 510(k) program to improve it and to address the increased complexity of new medical devices.

The agency said today that it has already taken several steps in this direction, including issuing a draft guidance clarifying when manufacturer changes to a device already on the market warrant a submission and taking steps to address the outstanding pre-amendment Class III device types that are subject to 510(k) review.

FDA also said that it has future plans to generate a draft guidance to "strengthen and streamline" the de novo classification path for low- and moderate-risk devices that are not substantially equivalent to existing devices, to draft a new "510(k) Paradigm" guidance to clarify its review process, and to issue a proposed rule on unique device holders.

The IOM committee also touched on a number of other aspects of the 510(k) process. It said that it "found substantial weaknesses" in the current practices for post-market oversight, and that it could be necessary for Congress to pass legislation enabling FDA to remove any barriers to its use of post-market authority to collect, analyze, and take action on information about devices' performance after they are on the market.

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