UDI deadline

The Class II UDI deadline is past. Enterprise labeling is the future.

Susan Gosnell Life Sciences Leave a Comment

Last month, the UDI deadline for Class II devices came and went and many medical device manufacturers breathed a collective sigh of relief.  Others are taking advantage of the extension for convenience kits and repackaged single-use devices, or still working to get their labeling and data organized for GUDID submission. Last week, at the Medical Device Labeling Conference in Phoenix, …

UDI Cover - banner

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 …

Who bears responsibility for submitting UDI data to the GUDID

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”). Which company qualifies as the device labeler? The next question to ask is which company (or companies) involved in bringing …