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FDA grants labeling extension to class 3 contact lenses, IOLS
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The U.S. Food and Drug Administration announced on its website that the Center for Devices and Radiological Health has granted a 1-year extension of the Sept. 24, 2014, Unique Device Identification System compliance date for various class 3 medical devices.
According to the FDA, the following devices are included: gas-permeable contact lens (extended wear), orthokeratology contact lens (overnight), soft (hydrophilic) contact lens (extended wear), intraocular lens, multifocal IOL, accommodative IOL, toric optics IOL, phakic IOL and iris reconstruction lens.
On Sept. 24, 2013, the FDA published a final rule establishing a Unique Device Identification System (the UDI Rule). According to the FDA, the UDI Rule outlines labeling, date submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S.
The FDA explained that the rule will be phased in over a 7-year period with an established set of compliance dates. According to the announcement, certain labelers of the contact lens and IOL industries notified the FDA that the UDI Rule would result in an extremely large number of data submissions to the Global Unique Device Identification Database (GUDID). The 1-year extension will allow the FDA to work with the affected labelers to develop an approach to ensure that data submission to the GUDID goes smoothly.