The Institute of Medicine (IOM), one of the four agencies that comprise the National Academies, is calling on the U.S. Food and Drug Administration to overhaul the 35-year-old 510(k) approval process for medical devices, a system that greatly expedites the approval of new devices if they are substantially similar to already-approved devices. The FDA uses this “fast-track” approval method to speed medical devices such as pacemakers, hip implants, and hernia patches to market. In recent years, however, the fast-track process has allowed an alarming number of flawed medical devices to enter the marketplace, creating serious injury or worse to thousands of Americans.

According to the Institute of Medicine, “the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and cannot be transformed into one.” The IOM says that the FDA’s resources “would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II (low- to moderate-risk) devices throughout the duration of their use.”

The IOM concluded that the FDA’s reliance on “substantial equivalence” alone in approving medical devices and allowing them into the market doesn’t and can’t assure that those devices are safe and effective. While many devices ultimately prove to be safe, many devices have unforeseen adverse effects on patients, which in turn has a damaging effect on the industry, the IOM reported.

While the IOM was not asked to develop a new framework for approval, it did discuss “key attributes of an improved process, including that it be clear, fair, and predictable, and make use of regulatory tools and authority to ensure safety and effectiveness throughout the duration of a product’s use.”

As for post-market surveillance of approved medical devices, the IOM said the FDA should have a “robust” ability to monitor and authority to enforce, yet by the agency’s own admission it has neither. “FDA should analyze what barriers hamper the efficient and effective use of its regulatory tools and identify ways to overcome them,” the IOM reported. “If necessary, Congress should pass legislation to remove barriers to FDA’s use of postmarket regulatory authority.”

The IOM report echoes earlier findings by the Government Accountability Office (GAO), which advised the FDA in January 2009 to take immediate steps to address flaws in the 510(k) approval process. The GAO’s advice essentially went unheeded and 67 more medical devices were sped through the FDA approval process.

Devastating problems with two of the hip-implant systems manufactured by DePuy Orthopaedics, which were approved through 510(k) and recalled last year after being implanted in some 93,000 patients, sounded the alarm yet again and helped draw attention to the flawed approval system.

Read the National Academies press release
Read the OIM Letter to the FDA



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