FDA UDI Final Rule &Draft Guidance Overview Slides

FDA published slides presented by Jay Crowley of CDRH providing an overview of the Final Universal Device Identification Rule and the draft guidance. These slides highlight some of the important aspects of the final rule including changes from the draft rule. This includes that standalone software need only provide a means to display a human readable UDI. The full presentation is at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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