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The 8-page document describes the requirements for and FDA’s recommendations regarding the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).
Final guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
