Recall Of Cordis Stent System High-Risk Class I, US FDA Says
The Precise PRO Rx US Carotid System was yanked from shelves because the device could separate during use.
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Jeff Shuren, director of the US FDA’s Center for Devices and Radiological Health, said on 6 May that the agency’s efforts around harmonizing its Quality System Regulation with ISO 13485 are “back on track.”
US FDA device center director Jeff Shuren on 6 May shed a tiny bit of light on the agency’s newly announced – but not defined – Inspectional Affairs Council.