510(k) Reform on a Highwire

Monday, July 20, 2015

Source: MD+DI

As another 510(k) safety issue emerged in July and an injured-patients’ legislative 510(k) reform effort took an unexpected hit on Capitol Hill, the prospects for significant change in the status quo seemed to be wobbling on a high-wire act.

The pivot-point is a basic question first presented by a controversial and widely ignored 2011 Institute of Medicine committee report that concluded that FDA’s 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” It recommended scrapping the process and starting over.

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