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Class I Device-Makers Get Wiggle Room As US FDA Pushes UDI Compliance Date To 2020

 
• By Shawn M. Schmitt

Manufacturers of low-risk class I products were given an extra two years to comply with FDA's Unique Device Identification requirements to give the agency and industry time to work through challenges posed by incorporating device identifiers into electronic health systems.

Makers of low-risk class I devices have an extra two years of wiggle room to comply with US FDA's Unique Device Identification program thanks to a deadline extension from the agency.

Class I device and unclassified product manufacturers originally had until September 2018 to add UDI to labels, but according to a June 2 letter from FDA to industry,...

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