The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and should be replaced, reports Reuters.
FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, which oversees devices, said 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.”
There were problems with devices such as the high-profile recall last year of the DePuy unit artificial hips (Johnson & Johnson), and automated external defibrillators. There were 4,000 devices cleared for market in 2009, most cleared through 510 (k).
The IOM suggested the FDA start collecting information to build the new process, including post-market data for devices. Congress should then enact legislation to design the regulatory framework, according to the report.
Read the report here.