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Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Life Sciences Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

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Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Life Sciences Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). The next question to ask is which company (or companies) involved in bringing a particular device to market qualifies as …