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Late last week, the Institute of Medicine (IOM) released a report criticizing the US Food and Drug Administration’s (FDA’s) 510(k) clearance process for medical devices and called for the development of a completely new framework. "The 510(k) process cannot achieve its stated goals—to promote innovation and make safe, effective devices available to patients in a timely manner—because they are fundamentally at odds with the statutes that govern how FDA must implement the process,” said David Challoner, chairman of the IOM committee that created the report. FDA officials disagree. "I don't think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning," Jeffrey Shuren, head of FDA’s Center for Devices and Radiological Health, told a town hall audience in Minnesota this week. FDA intends to gather further public comment on the report through October.

Read more:

• Controversial IOM Report Highly Critical of 510(k) Process (Forbes)
• IOM to FDA: Medical device clearance not cutting it anymore (Government Health IT)
• FDA seeks more industry opinion about device approval process (Star Tribune, Minneapolis)
• Is There a Better Way To Approve Medical Devices? (Industry Week)
• Study of Medical Device Rules Is Attacked, Unseen (New York Times)