FDA issues Guidance on UDI - Frequently Asked Questions, Vol. 1


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Dear All

The US Food and Drug Administration (FDA) is issued a guidance document on “Unique Device Identification System: Frequently Asked Questions, Vol. 1 Guidance for Industry and Food and Drug Administration Staff”. This guidance document provides clarification of key provisions of the UDI Rule, it specifically addresses on UDI basics, UDI placement, the Global Unique Device Identifier Database (GUDID), and direct marking, as well as exceptions, alternatives and exemptions.

To access the guidance document, refer below FDA link



  • USFDA_UDI_FAQ Guidance.pdf
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