Attorney: Latest UDI guidance unhelpful, many questions left unanswered

The latest in a series of guidances explaining and implementing last year's Unique Device Identification final rule is "little more than a regurgitation of information contained in the rule itself, the preamble to the rule, the UDI website, and the Global Unique Device Identification (GUDID) guidance document," wrote medical device law attorney Jennifer Newberger. Indeed, the FAQ-style document appears to be intended as a primer on the topic but left experts' questions unanswered. For example, Newberger is still wondering if contact lenses count as implantable devices and worries that retailers may not be equipped to read the machine-readable UDI code for a number of years. She hopes that clarifications, such as the use of a UPC code as a temporary UDI, are made in Volume 2 of the guidance. Blog

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