Leveraging UDI Data for Regulatory Compliance and More
The FDA is no longer allowing devicemakers to use “legacy” alternatives to unique device identifiers (UDIs) and the agency is now more active in enforcing UDI requirements.
Ensure that you remain current with emerging international UDI requirements for medical devices and learn about the multiple uses of UDI data to support regulatory compliance as well as commercial and “quasi-regulatory” activities with Leveraging UDI Data for Regulatory Compliance and More, published by FDAnews, A WCG Company.
The report is based on a webinar presented by Jay Crowley, an expert with more than 25 years’ experience at the FDA, where he developed the framework and authored key requirements for the agency’s UDI system.
Leveraging UDI Data for Regulatory Compliance and More digs into the details of UDI and explains which information should appear on the device’s label as well as on the device itself. It also describes how UDI rules apply to medical device components and accessories.
- Understand how to properly use UDI to support regulatory and commercial use
- Learn the expectations of the FDA and other regulatory authorities for data alignment through UDI
- Understand the need for reuse of data across systems and outputs to address the needs of various stakeholders
- Master the global status of UDI adoption
About the Contributor
Jay Crowley, Vice President, Medical Device Solutions and Services, USDM Life Sciences
Jay Crowley held various positions in his 26 years at the FDA, most notably serving as the senior advisor for patient safety in the FDA’s Center for Devices and Radiological Health (CDRH). One of his principal achievements was developing the framework and authoring key requirements for the FDA’s UDI system to adequately identify medical devices sold in the U.S.
Who Will Benefit
- Regulatory Managers
- Design Engineers
- Labeling Specialists
- Project Managers
- Quality Managers
- Quality Engineers
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