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‘Cures’ Plan To Rely On 3rd-Party Audits For Some Device Changes Needs Tweaks, Shuren Says

Reliance upon a third-party assessment of quality systems for certain device modifications might eventually help industry, but it would “probably not” be efficient for FDA’s device center, as proposed in the House 21st Century Cures effort.

A third-party quality system assessment program proposed in a draft House “Cures” bill might be helpful to industry but would likely not be efficient for FDA, CDRH Director Jeff Shuren told lawmakers at an April 30 hearing on the draft bill.

The provision, crafted by Rep. John Shimkus, R-Ill., is given only placeholder text in the most recent draft, released April...

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