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# FDA Draft Guidance on UDI Issuing Systems
- URL: https://www.fdaweb.com/fda-draft-guidance-on-udi-issuing-systems/
- Published: 2016-07-25T12:00:00.000Z
- Updated: 2026-09-14T21:16:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136271

FDA has posted a [draft guidance](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM512648.pdf?ref=fdaweb.com) on “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)” that defines the expected content and forms to assist both labelers and FDA-accredited issuing agencies. The document is intended to ensure the UDI issuers are in compliance with the UDI System Rule. Under the rule, a UDI must be issued by an FDA-accredited issuing agency that operates a system that conforms to the international standards listed under 21 CFR 830.20\. The UDI must be presented in two forms on the label and device packages: easily readable plain-text and automatic identification and data capture technology codes.