IOM to FDA: Ditch the 510(k) clearance program for medical devices

The Institute of Medicine’s long-awaited report on the FDA’s 510(k) medical device review program, which dropped this morning, recommends that the federal watchdog agency ditch the program entirely and replace it with an “integrated pre-market and post-market regulatory framework.”

The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, is not binding on the agency but is sure to cause a stir in med-tech circles and draw the attention of members of Congress.

Sen. Scott Brown (R-Mass.), who has previously said that the FDA is throwing a “wet blanket” on innovation, told MassDevice that he’s got his eye on the report.

“I am reviewing the IOM recommendations in the context of MDUFMA reauthorization, with a critical eye on how these recommendations could further add to the uncertainty in the FDA regulatory process for the medical device industry,” Brown said in an email. “I will continue to closely follow and monitor these discussions, and listen to the device industry in Massachusetts about the proposed changes to the 510k process.”

The watchdog agency last summer adopted a slate of less-controversial changes to the program by which most medical devices are cleared for the U.S. market, but punted on implementing some of its more controversial proposals until publication of the IOM review.

With that out of the way, all eyes are on the agency as it digests the IOM’s recommendations and charts its course for what could be further, radical changes to the program.


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“It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying it again will not help,” said David Challoner, who chaired the committee that wrote the report. “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.”

FDA officials reacted quickly to the IOM’s recommendations, issuing a statement saying that while none of the institute’s edicts were binding, the agency would be planning a public meeting in the coming weeks. Officials at the agency have been somewhat distancing themselves from the report for several weeks now in both congressional hearings and negotiation meetings for reauthorization of the Medical Device User Fee and Modernization Act with industry.

“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said in a prepared release.

“Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. 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.

The reaction from the medical device industry was swift and condemnatory.

“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” said Stephen Ubl, president and CEO of the Advanced Medical Technology Assn., in prepared remarks. “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.”

“Numerous academic studies have shown that the 510(k) process is overwhelmingly safe. 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. It even goes so far as to say that further investment in 510(k) process improvements would not be ‘a wise use of FDA resources.'”

Medtronic Inc. (NYSE:MDT) officials were less damning of the IOM’s report, opting instead for cautious support of the FDA.

“We are in the process of reviewing and assessing the complete IOM report,” Medtronic spokesman Steve Cragle told MassDevice via email. “As a company, we are supportive of regulatory changes [that] will continue to add clarity and consistency to the process and are in the best interest of patients, including ensuring that innovative therapies can reach the market.”

“We agree that any changes made to review process, which has a strong safety record, should be based on sound science and through thoughtful and transparent discussion. We are committed to working with the FDA, Congress and others throughout this process,” Cragle told us.

The IOM review concluded that the 510(k) program fails to ensure that Class II medical devices are safe and effective before they hit the U.S. market. The agency should “gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices,” according to a press release.

“The 510(k) process lacks the legal basis to be a reliable pre-market screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one,” the IOM committee found. “FDA’s finite resources would be better invested in developing a new framework that uses both pre-market clearance and improved post-market surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use, the committee said. The agency should also ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.”

The institute took issue with the foundation of the 510(k) program, that devices which are “substantially equivalent” to already-approved products (so-called “predicate devices”) need not be subject to the more stringent pre-market approval process required for entirely new medical technologies.

“[R]eliance on substantial equivalence cannot assure that devices reaching the market are safe and effective,” according to the IOM release. “The majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness. This does not mean that they or the devices that followed them are unsafe, and the continual use of many of these products in clinical practice provides a level of confidence in their safety and effectiveness,” the committee said. “But 510(k) clearance does not determine a device to be safe or effective.”

“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,” Challoner 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 they are fundamentally at odds with the statutes that govern how FDA must implement the process. While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame.”

And although it’s short on specifics about how the new program should entail, the IOM review suggests that the FDA “explore whether a modified version of its de novo process could replace the 510(k) process.”

“The de novo process reduces the amount of information manufacturers must supply for devices deemed to be of low or moderate risk but that have no predicate devices against which to be compared,” according to the institute. “Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before FDA initiates a pilot program.”


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