FDA UDI Final Rule &Draft Guidance Overview Slides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slides presented by Jay Crowley of CDRH providing an overview of the Final Universal Device Identification Rule and the draft guidance.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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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