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GUIDANCE DOCUMENT

Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 Guidance for Industry and FDA Staff August 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

On September 24, 2013, FDA issued regulations establishing a unique device identification system for medical devices along with implementation timeframes for certain medical devices (78 FR 58786) (the UDI Rule). FDA established a set of compliance dates, by device classification, for compliance with required labeling and data submission to the Global Unique Device Identification Database (GUDID) under the UDI Rule. For class III devices and devices licensed under the Public Health Service Act, the compliance date was September 24, 2014. FDA granted requests for extensions to the compliance date some of which expire on September 24, 2015. For implantable, life sustaining and life supporting devices (other than class III devices which had a compliance date of September 24, 2014), the compliance date is September 24, 2015.

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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