UDI System: The Final Regulation - Free FDA CDRH Video

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"Unique Device Identification (UDI) System"

This is a collection of many presentations. Each of the presentations includes:

• the presentation
• printable slides, and
• a transcript

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Unique Device Identification (UDI) System - FDA Final Rule

Press Announcements > FDA finalizes new system to identify medical devices:

" . . . the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.

The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule."

Follow this link to view the Unique Device Identification System - Final Rule (PDF)

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FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:

• batch failure rate
• right first time, and
• out-of-specification (OOS)/laboratory failure investigation rates"

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