Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule). The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be
Extension Letter to Class III Contact Lens and Intraocular Lens Labelers August 15, 2014 FDA issues the following letter. Dear Class III Contact Lens and Intraocular Lens Labelers: Effective August 15, 2014, the FDA’s Center for Devices and Radiological Health (CDRH) is granting a 1-year extension of the September 24, 2014 Unique Device Identification System (UDI) compliance date for the
