US FDA expands UDI training resources for medical device companies

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published five new training and education modules on the online platform for the agency’s Unique Device Identification (UDI) program.

Available on the FDA’s CDRH Learn website, the new modules cover areas including:

• An overview of the FDA UDI system and regulations, data and label requirements and implementation schedules
• Preparing a Global Unique Device Identification Database (GUDID) account request and creation
• GUDID Device Identifier Record requirements and submission options
• GUDID HL7 SPL submission options, formats  and other requirements
• How to submit data to GUDID using appropriate submission options

UDI compliance requires significant effort for many US medical device registrants, and continues to generate many questions and concerns from industry. Hopefully these additional training modules from US regulators will address some (if not all) of these issues for companies.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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