FDA Unveils UDI Proposal


Ralph F. Hall, +1 317 569 4619, ralph.hall@FaegreBD.com

Libby L. Baney, +1 202 312 7434, libby.baney@FaegreBD.com

Right as everyone left for a (sweltering) Fourth of July break, the Center for Devices and Radiological Health (CDRH) released its proposed Unique Device Identification (UDI) rule. The Food and Drug Administration (FDA) has been under increasing pressure from Congress and other stakeholders to finish this proposed rule and released the proposed rule just as President Obama was getting ready to sign legislation requiring them to do so. The basic idea behind UDI is that essentially all medical devices of any complexity would have a unique alphanumeric coded identification number on its label and, in some cases, on the device itself…

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