After commissioning the Institute of Medicine (IOM), a widely respected part of the National Academy of Sciences, in 2009 to examine specific procedures and regulatory pathways used to approve medical devices, the FDA may not be so pleased with their findings. In the report released Friday, the IOM review panel, consisting of 12 experts, unequivocally recommended that the FDA scrap its current system for evaluating moderate-risk medical devices: they deemed it beyond repair. The report analyzed the agency s 510(k) clearance process, which evaluates devices such as artificial hips and external heart defibrillators, but did not examine high-risk products. Under the current system, new 510(k)-approved devices can go to market if they are substantially equivalent to those already available, so that they are simply piggy-backed on earlier devices without significant review of their safety or efficacy.
There s no doubt that the rules governing low- or intermediate-risk medical devices are more lenient than those used to approve drugs, says ACSH's Dr. Elizabeth Whelan, yet there is also no doubt that a more stringent system may lead to a lack of access to new devices, which could be a detriment to certain patients.
The IOM panel has advised that the FDA extend the same type of rigorous scrutiny used for high-risk devices to lower risk devices, while also recommending the agency keep better track of the performance of these products once they reach the market.
Jeffrey Shuren, M.D., director of the FDA s Center for Devices and Radiological Health, responded thusly: 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.
Though we certainly don t want to encourage the sale of devices that pose a greater risk than benefit, we also want to ensure that patients are not denied products they need, says ACSH's Dr. Gilbert Ross.
