FDA's new unique device ID timing cuts deadlines for some device labels by 5 years

Tue, 11/20/2012 - 10:15am
Mass Device

New unique device identifier deadlines required by a law signed earlier this year force the FDA to shorten some of its labeling timeframes by as much as 5 years.

FDA UDI example

The FDA's UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

The FDA issued new timelines for its long-awaiting "unique device identifier" system for tracking and monitoring medical technology, cutting short some deadlines for implementation by as much as 5 years in order to comply with a new law.

The FDA Safety & Innovation Act, signed into law July 9, 2012, requires that all "implantable, life-saving (life-supporting), or life-sustaining" devices comply with UDI requirements within 2 years of publication of a final rule.

The federal watchdog agency had initially planned a phased launch of the UDI program, requiring Class III devices to comply fully within 1 year but staggering requirements for Class II and Class I devices of 3, 5 and 7 years.


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