Regulatory Focus™ > News Articles > Jay Crowley, Author of FDA's UDI Rule, to Leave Agency for Industry Next Week

Jay Crowley, Author of FDA's UDI Rule, to Leave Agency for Industry Next Week

Posted 20 December 2013 | By Alexander Gaffney, RAC

Jay Crowley, the US Food and Drug Administration's (FDA) author of the Unique Device Identification (UDI) rule and a longtime employee of the agency, will soon retire to join industry, agency officials confirmed today.

The news first broke on 19 December 2013, when USDM Life Sciences, a global regulatory consulting firm, announced that it had hired Crowley as its Vice President of its UDI practice.

"There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA's compliance rules," the company said in a statement.

Crowley has been with FDA for 27 years, and his departure from the agency comes just months after he succeeded in finalizing its UDI rule after nearly a decade-long struggle to bring it into existence.

"I'm looking forward to helping the medical device industry move forward with UDI compliance and help them utilize the benefits of UDI [at USDM]," Crowley was quoted as saying in a statement provided by USDM.

FDA officials confirmed Crowley's impending retirement to Focus on Friday, saying that the agency "[doesn't] anticipate any changes to how we implement UDI."

"We have excellent staff at CDRH who have been and will continue to work on implementation of this important rule," Jennifer Rodriguez, a press official, wrote. The agency has not yet decided who will fill Crowley's position, but hopes to do so "as quickly as possible," she added.

Crowley will leave FDA at the end of December, FDA said, and will start as USDM on 6 January 2013.


USDM Statement


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