FDA has issued the final guidance dealing with unique device identifiers (UDIs) and has made allowances for UDIs on implant devices and for inventory manufactured prior to the date of compliance. Two industry associations applauded the agency for making adjustments for the concerns expressed by device makers, although both indicated in formal statements that they are withholding judgment pending a more extensive review. One point FDA did not bend on was the timeline for compliance, although the agency indicated it would flex on the one-year deadline for class III devices in some cases. Read More
