Unique Device Identification

Jay Crowley explains some of the benefits of a UDI system.

As Vice President of the UDI Practice at USDM Life Sciences, Jay helps medical device manufacturers achieve regulatory compliance as well as internal benefits and competitive advantage with UDI implementation. The FDA UDI Final Rule requires that most medical devices distributed in the United States carry a unique device identifier, or UDI.

Jay held various positions over nearly 27 years at the FDA. Most recently, he was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. Jay had primary responsibility for the development and implementation of the FDA’s Unique Device Identification System.

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