Future of UDI in Healthcare Systems

Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences and former FDA Senior Advisor, led a session on the future of Unique Device Identification (UDI) in healthcare systems at the 2014 UDI Conference. He noted the UDI Rule is flexible, extendable and the conceptual regulatory framework is good; however, we are all learning -- it is an iterative process. As the original legislation called for the use of device identification through “distribution and use,” there is a lot of work to be done to achieve the public benefits of UDI. The Rule was designed to evolve and grow. To improve FDA’s post market surveillance activities, the Rule’s conforming amendments mandate the UDI in adverse event reports from healthcare providers and manufacturers. So what’s next? Talk to your stakeholders, trading partners and issuing agencies about standards.

We’re listening, email us your thoughts at ComplianceSolutions@usdm.com.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet regulatory requirements, including the Drug Supply Chain Security Act, Unique Device Identification and Meaningful Use Rule.

** The FDA Amendments Act (FDAAA) of 2007 and FDA Safety and Innovation Act (FDASIA) of 2012 amended the Federal Food, Drug, and Cosmetic Act directed FDA to establish a UDI system.