UDI Architect Jay Crowley Leaves FDA

Posted in Regulatory and Compliance by Jamie Hartford on February 19, 2014

By Jim Dickinson


CDRH patient safety senior advisor Jay Crowley has retired from FDA to join regulatory consulting firm USDM Life Sciences as vice president of its unique device identification (UDI) practice.

At FDA, Crowley developed the framework and authored key requirements for the agency’s UDI system.
“There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA’s compliance rules,” USDM says.

Crowley served 27 years at the agency and held a variety of positions, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting. Crowley also worked in the Office of the Commissioner and CDRH’s Office of Compliance. He had received high marks from industry for his work on the UDI rule.

Jim Dickinson is MD+DI's contributing editor. 

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