A program allowing U.S. regulators to approve moderate-risk medical devices in an average of 10 months instead of years shouldn’t be scrapped, the Food and Drug Administration said in response to an advisory panel report.
The Institute of Medicine, asked by the agency to review the program, urged the FDA today to abandon use of the so-called 510(k) process to clear a class of devices that include orthopedic implants and x-ray machines. The system is used to evaluate products similar to those already cleared, or about 90 percent of applications. The FDA said it would put the institute’s recommendation up for public comment.
“We are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, in a statement.
The FDA should direct device makers such as Johnson & Johnson (JNJ) to prove each moderate-risk, or Class 2, product is safe and effective on its own merits, the institute said today. The report, which isn’t binding, follows by a month a Government Accountability Office finding that 83 percent of 700 devices recalled on average yearly are Class 2.
“A move away from the 510(k) clearance process should occur as soon as reasonably possible,” for moderate-risk devices, the institute wrote in a 165-page report. Lesser risk, or Class 1, products can still be measured by a process similar to the 510(k) program, said the institute, an arm of the National Academy of Sciences in Washington.
The agency is taking public comments on the institute’s recommendations. The FDA spent about $870,000 per device for more extensive reviews that require human studies, compared with $18,000 for the less-involved 510k application, according to the GAO, which used 2005 figures, the most recent available.
The report is intended to start a conversation that will lead to changes in a few years, David Challoner, chairman of the institute panel and emeritus vice president for health affairs at the University of Florida, Gainesville, said by phone. The FDA couldn’t initiate such a discussion “because of legislative and other concerns,” he said.
The recommendation, if put in place, would squelch product development and add uncertainty to reviews that are already slow and unpredictable, said Dave Fisher, executive director of the Medical Imaging and Technology Alliance, which represents device makers that include General Electric Co. (GE), of Fairfield, Connecticut and San Francisco-based McKesson Corp.. (MCK)
Approving such a change “would be inhibiting innovative technology from reaching patients for clinical trials, for technology that’s already widely known,” Fisher said in a telephone interview. “You don’t need a clinical trial to know that a radiation therapy device, that its output will kill cancer cells. We know what will happen with an X-ray machine.”
Imaging and radiation devices are generally moderate-risk devices. Even with industry complaints about the process, the 510(k) program and its reliance on comparisons to similar devices should remain the FDA’s standard, he said.
Products that have had recall and failure issues would likely face the most scrutiny under the institute’s plan, including metal-on-metal hips and infusion pumps, said Mike Matson, a senior analyst at Mizuho Securities USA in New York. J&J, based in New Brunswick, New Jersey, makes metal-on-metal hips while Baxter International Inc. (BAX) in Deerfield, Illinois, is a leader in infusion pumps.
“If the IOM supports these things the whole probability of these things happening does go up,” Matson said in a telephone interview.
‘A Higher Standard’
Devices that are implanted and “life-sustaining and life- saving should be held to a higher standard,” said Diana Zuckerman, president of the National Research Center for Women and Families in Washington, by telephone.
The FDA requested the institute review after a set of proposals it was considering to change the approval process for devices drew concern in public comments, the agency has said.
The FDA “would rather Congress weigh in” than use its administrative power to act on the more controversial recommendations, said Eric Assaraf, an analyst with MF Global Washington Research Group, in a telephone interview. ‘This is mostly headline risk because we think that FDA doesn’t want to or won’t act” on the recommendations.
The institute did not detail a new clearance process, saying the FDA should determine what evidence it needs to show a product safe and effective.
The institute’s report also suggested the FDA focus on combination products, such as medical software, nanotechnology and medical robotics, as it develops its new regulatory reviews system and recommended it create programs similar to the 510(k) system for innovative products that pose a low risk to patients.
These products may require post-market reviews, patient registries and human trials, the report said.
Congress has already weighed in with concern over the FDA’s approval process. A bipartisan group of lawmakers wrote the agency late last year and again in January, expressing concern with the effects of tougher regulatory reviews.
The FDA released a preliminary report on its 510(k) overhaul in August 2010 and is implementing some changes this year, including releasing guidance to help manufacturers improve clinical trials and streamline the process for some low-risk products.
The agency also said it would improve communication about when clinical data should be submitted in support of a 510(k) application.
The Washington Legal Foundation petitioned the agency to refuse any advice from the institute, arguing manufacturers and inventors weren’t represented on the advisory board.
The agency had no control over who is assigned to the committee, FDA Commissioner Margaret Hamburg said at a Senate hearing yesterday.
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