AAMI article on FDA UDI Accredited Organizations

The link provided announces that FDA has accredited the first two organizations (GS1 US and Health Industry Business Communication Council (HIBCC)) to allocate UDI identifying codes. This is required under the new FDA UDI rule which requires all medical devices to have a unique identifier.

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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