Simplifying Global Compliance
New Direct Marking Requirements for UDIs - Webinar Recording/Transcript
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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:
- How the definition of “intended to be reprocessed” for purposes of UDI direct marking has changed from draft to final rule (it now identifies which devices are subject to the additional direct marking requirement)
- Whether “single patient use” devices — ones which the patient reprocesses — fall under the direct mark requirement
- What the final guidance says about how consigned or loaned devices will be treated for the purposes of the direct mark requirement
- How long the FDA believes the direct mark UDI should last
- How the existing-inventory exception affects those devices also subject to the direct mark requirement
- FDA recordkeeping requirements for devices that must be directly marked
- And much more!
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.
- Regulatory affairs
- Design engineers
- Labeling specialists
- Project managers
- QA/QR/QC
- Quality Engineers
- Executive suite
- R&D
- Strategic Planning Staff
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.
