In a scorching report released Friday, the Institute of Medicine said the 510 (k) program is an ineffective tool for establishing the safety and effectiveness of moderate risk Class II medical devices such as artificial hips.
Instead of attempting to modify the program, the IOM wants the FDA to scrap it and develop a new framework for review that "integrates pre-market clearance and post-market performance to assure the safety and effectiveness of a medical device through its life cycle."
The FDA, which commissioned the IOM report in September 2009, noted in a statement that the IOM's recommendations are nonbinding. "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," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.
Critics have long called for changes in the 510(k) program, which reviews about 4,000 applications each year, to bring medical device review in line with the strict standards applied to new drug releases. The FDA proposed in January its own plan to change 510 (k) but was criticized then for deferring any consideration of creating a subset of Class II medical devices that would require a more rigorous review than other devices in the class.