FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

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Jul 10th, 2021

Devices Getty Images 624567292 Sep Oct 2018

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)

Devices Getty Images 624567292 Sep Oct 2018

FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)

The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

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