The US Food and Drug Administration plans to revamp its approach for clearing medical devices, including in vitro diagnostic products, as GenomeWeb has reported.
As the Associated Press adds, FDA's method for clearing most medical devices dates back to 1976 and has been long criticized. The approach relies on manufacturers showing that their devices are substantially similar to items already on the market, but, the AP adds, many devices going through 510(k) clearance are more complicated and don't always resemble the device they are supposed to be similar to.
In 2011, an Institutes of Medicine report called on the agency to do away with its 510(k) medical devices clearance program and instead adopt a hybrid approach combining both pre-market and post-market review. At the time, Jeffrey Shuren, the director of FDA's Center for Devices and Radiological Health, said the agency believed "the 510(k) process should not be eliminated" though noted it was "open to additional proposals and approaches."
As GenomeWeb now reports, Shuren and FDA Commissioner Scott Gottlieb say the 510(k) approach should take technological advances and modern safety and performance requirements into consideration. "We believe that newer devices should be compared to the benefits and risks of more modern technology," Gottlieb says in a statement.
The AP notes that this shift comes on the heels of the publication of an investigation into medical device safety by numerous media outlets.