The FDA, however, says its 510(k) process needs to change with the times - as devices advance, the process used to clear them must advance as well.

The FDA's Center for Devices and Radiological Health "uses science to guide its regulation of medical devices across the total product life cycle. At any stage of that life cycle, new, unfamiliar or unexpected scientific information may arise that warrants a change in the FDA's thinking, expectations and actions. CDRH is seeking to strike the right balance between the ability to adapt its approach as new science emerges, and to provide predictable regulatory pathways," according to a CDRH report released last month.


FDA spokesman Dick Thompson pointed out that the AdvaMed study doesn't mention the associated benefit of a device, which is part of the equation when it comes to the 510(k) process.

He recognizes the success of the process, but noted that it's not perfect.

"The FDA's 510(k) program generally works, but it needs strengthening in order to remain a viable program that fosters device innovation and promotes patient safety," Thompson said in an e-mail to DOTmed News. "The [CDRH] reports don't seek profound changes to the program -- rather they seek to clarify and strengthen the current process in order to make it more predictable and
reliable, both of which are extremely important to device innovation."

The public comment period for the recommendation closes Oct. 4.

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