United States medical device QA/RA blog

News and commentary on regulatory changes.

US Regulators Extend UDI Deadlines Following Security Issue

Citing security vulnerabilities, the US Food and Drug Administration has extended deadlines for compliance with a key component of the agency’s Unique Device Identification (UDI) system.

FDA GUDID compliance deadline extension for medical devicesRequirements for submitting labeling and data for implantable, life-supporting and life-sustaining devices to the FDA’s Global Unique Device Identification Database or GUDID, originally given a September 24 2015 deadline, must now be met by October 24, 2015.

This new deadline also applies to Class III devices whose manufacturers have filed for and obtained compliance extensions that expire between August 7 and September 24 2015.

GUDID was taken offline August 7 after the discovery of a “security vulnerability,” the nature of which was not disclosed in the FDA notice

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