divendres, 21 de novembre del 2014

US FDA delays UDI compliance deadline for some single-use implantable devices




The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.





Emergo Group

By Stewart Eisenhart, Emergo Group


Medical device regulators in the US have extended their Unique Device Identification compliance deadline to September 24, 2016 for some implantable medical devices to provide more time for manufacturers of these devices to develop and implement workable UDI processes.


In order to qualify for the extension, a device must meet three key criteria:




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