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New Direct Marking Requirements for UDIs: How to Comply with the Final Guidance
The FDA’s final guidance on UDI (unique device identification) raises as many questions as it answers. With full compliance for Class I, II and unclassified devices looming, lawyers are hard at work parsing the FDA’s language.
The stakes for devicemakers are high. Getting compliance right spells profits, while getting it wrong spells penalties — and possible liability lawsuits too.
Jay Crowley was the architect of UDI while at the FDA. Now a consultant advising devicemakers, he remains the go-to expert on UDI compliance.
And Mr. Crowley is ready to tell all.
Spend 90 minutes with Mr. Crowley that readies you for full UDI compliance. In this presentation, you’ll discover:
Full compliance is looming. (Sept. 24, 2018, for Class II devices; Sept. 24, 2020, for Class I and unclassified devices.) Now is the time to sort out the likely impact of this key regulatory action.
Jay Crowley, former Senior Advisor for Patient Safety in FDA’s Center for Device and Radiological Health, is now Vice President, Unique Device Identification Services and Solutions, at USD Life Sciences. At the FDA, he developed the framework and authored key requirements for the agency’s Unique Device Identification (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,” Crowley’s new employer asserts.
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