Makers of contact lenses and intraocular lenses are getting a 1-year reprieve after the FDA agreed to shift their due date for complying with Unique Device Identifier rules.
Manufacturers successfully lobbied for a delay after demonstrating that requirements for lenses would create a massive burden for both device makers and regulators.
"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," according to an FDA notice. "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."
Contact and intraocular lenses, like other Class III (PMA) medical devices, were supposed to get UDI labels by Sept. 24, 2014. The new deadline is Sept. 24, 2015. For companies that have already fulfilled their compliance requirements, the extension means they won’t have to submit their data to the global database until next year.
The FDA finalized its UDI rule in September 2013, to a mixed reaction from the medtech industry. The UDI rule requires most medical devices to carry unique labels with scannable barcodes that will allow healthcare providers, regulators and the public at large to track the devices and monitor their safety. The program will assign unique codes to most medical devices and gather data to be stored in a publicly accessible database.
Canadian regulators announced this summer that they plan to launch their own UDI program based on the FDA’s framework.
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