FDA Grants Certain Contact Lenses and IOLs One-Year Extension of UDI Rule

According to a recent report from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), manufacturers of Class III contact lenses and intraocular lenses (IOL) will get a year’s reprieve from the newly established Unique Device Identification (UDI) System requirements.

CDRH is granting a one-year extension of the Sept. 24, 2014, UDI compliance date.

On Sept. 24, 2013, the FDA published a final rule establishing a unique device identification system.  The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the United States, unless an exception or alternative applies, according to a recent post on the FDA website.

The extension includes rigid gas-permeable contact lenses (extended wear); orthokeratology contact lenses
(overnight); soft (hydrophilic) contact lenses (extended wear); IOLs; multifocal IOLs; accommodative IOLs; toric optics IOLs; phakic IOLS; and iris reconstruction lenses.

The rule will be phased in over a seven-year period through an established set of compliance dates. The compliance date for class III devices is Sept. 24 this year.

“Recently, certain labelers of the contact lens and IOL industries notified the FDA of a UDI labeling strategy being employed for these devices that would result in an extremely large number of data submissions to the Global Unique Device Identification Database (GUDID),” FDA officials wrote. “Not only would the volume of submissions greatly exceed the best estimates previously available to the FDA, we have also learned that many of these submissions would be virtually identical files. Pursuant to 21 CFR 801.55(d), the FDA has determined that initiating and granting a one-year extension would be in the best interest of the public health. This additional time will allow the FDA to work with the affected labelers to develop an approach to ensure that meaningful data will be submitted to the GUDID.”