FDA Responds to IOM Report Concerning 510(K) Process

IOM Device Report Gets Strong Response

By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 29, 2011

WASHINGTON -- The FDA reacted swiftly to the Institute of Medicine's recommendation that the agency's 501(k) medical device approval process be abandoned; so did industry and patient groups. In a press release sent just minutes after the IOM report was released on Thursday, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said the agency doesn't think the fast-track approval process for moderate-risk devices should be scrapped. "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. Then on Friday morning the agency announced that it would open a public docket to accept comments on the report, and hold a public meeting in the next few weeks. The IOM report -- written by a 12-person panel of doctors, lawyers, and academics -- concluded that the 510(k) process does not ensure safety or effectiveness of medical devices and needs to be replaced with a new regulatory framework. The majority of devices -- ranging from tongue depressors to pacemakers -- go through the fast-track 510(k) approval, which was established under the 1976 Medical Device Amendments to deal with the growing array of medical devices. To earn 510(k) approval, companies seeking approval for a low-to-moderate risk device must prove that the it is substantially similar to another device already on the market. Unlike the premarket approval process -- which is used for brand-new devices and high-risk devices -- a company does not have to provide clinical data to support its contention that its device is safe and effective. The FDA commissioned the report from the IOM, but it doesn't have to follow the advice of the committee. Three of the authors of the IOM report who spoke at a public event on Friday said they thought it was a good idea that the FDA open the group's recommendations up for public comment. Industry Weighs In The FDA may have been tempered in its reaction to the report, but the device industry didn't hold back in its total disagreement with the IOM's recommendations. "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 Association (AdvaMed), in a press release. "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." Ubl said numerous studies have shown the 510(k) process is "overwhelmingly safe." The IOM committee didn't say that the process was unsafe, just that it isn't set up to ensure safety or efficacy. The Medical Imaging & Technology Alliance (MITA) said it was "concerned and disappointed" by the recommendation to get rid of the 510(k) process, saying it falls "far outside the current conversation" on how to improve FDA's device approval process. "The IOM has offered the wrong approach," Dave Fisher, executive director of MITA, said in a press release. The device industry has been highly critical of the FDA's device review process, calling it unpredictable and sluggish to approve new devices, which they say is hampering innovation and causing medical device manufacturers to seek approval outside of the U.S. AdvaMed and MITA both support the 25-step plan announced by the FDA earlier this year, but those who have pushed for tougher device regulation criticized the plan for being watered down and said it wouldn't do much to improve device safety. Patient Groups Are on Board Patient and consumer advocates, on the other hand, praised the IOM report. "We applaud the report for its findings and recommendations and we think they are critically important," Michael Carome, MD, deputy director of Public Citizen's health research group, told MedPage Today. Public Citizen has long asserted that the 510(k) process allows potentially unsafe devices on the market. "It's clear that devices that are not safe and effective are making their way to market and that reflects a failure in the current system," Carome said. He said he disagrees with the FDA's response that the 510(k) process does not need to be discarded and said he hopes the agency takes more time to consider the IOM's recommendations. Diana Zuckerman, PhD, president of the National Research Center for Women and Families, who agrees with the report findings, said the report must have came as a "big shock" to the FDA. "I think for all of us who work within the system, it's shocking when an outside entity says, 'This whole system is crazy' even when I think all of us know that this whole system is nonsensical," she told MedPage Today. Zuckerman said there are four major problems with the 510(k) process: It doesn't require device-makers to submit clinical trials; it doesn't mandate inspections of manufacturing facilities; it doesn't require post-marketing studies; and it doesn't give the FDA any authority to rescind approval if the device is found to be unsafe or ineffective. However, the FDA does not have the resources to "fix the system in the way that really does the job at the moment," she acknowledged. The device side of FDA is much less well-funded that the drug side, because pharmaceutical companies pay user fees that are 10 times higher than those paid by device companies. Zuckerman said device companies should be paying higher user fees in order to help fund a safer device approval system.