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Regulatory Briefs: UDI Guru Crowley Heads To Industry; Reclassification Website; Post-Market Planning Board

Jay Crowley, the principle architect of FDA’s UDI regulation, is leaving the agency. FDA announced the launch of a website tracking the reclassification of device types, the accreditation GS1 as a UDI issuing agency and improvements to its device recalls database. More regulatory news.

Jay Crowley, FDA’s senior advisor for patient safety who headed the agency’s work on the unique device identification system regulation, is leaving FDA at the end of December to join USDM Life Sciences, the firm announced Dec. 19. He will start at USDM on Jan. 6, and will focus exclusively on providing business process, technology and compliance solutions for the regulated life science industry. “There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA's compliance rules,” said Kevin Brown, managing partner at USDM Life Sciences, in a statement.

Crowley has worked at FDA for 27 years, and spent 10 of those years developing the UDI system and global database to track and trace medical devices. (See Also see...

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