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