Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) Draft Guidance for Industry and Food and Drug Administration Staff July 2016

GUIDANCE DOCUMENT

• Docket Number: FDA-2016-D-1853
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

When finalized, this draft document will clarify for industry, FDA-accredited issuing agencies, and FDA staff the requirements under 21 CFR 801.40. Specifically, this draft guidance defines the expected content and forms of the Unique Device Identifier (UDI), to assist both labelers, as defined under 21 CFR 801.3, and FDA-accredited issuing agencies, as defined under 21 CFR 96830.3, to better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the Unique Device Identification System Rule, 78 FR 58786 (September 24, 982013) (UDI Rule).

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