Putting an end to an issue that has plague lens manufacturers, the FDA has declared Rx lenses exempt from a regulation that requires medical devices to have Unique Device Identifier (UDI) labeling. The exemption comes after nearly two years of advocacy by The Vision Council.
The Vision Council reports that, in a letter dated April 3, 2017, the FDA agreed that lens manufacturers, optical labs, and eyecare providers are not subject to the UDI’s labeling and reporting requirements. The letter stated:
“The labeler of each device is responsible for meeting the labeling and data submission requirements in the UDI System rule. Based on the information [The Vision Council] provided to FDA and FDA’s current interpretation of the FD&C Act and its implementing regulations, prescription lens manufacturers, optical laboratories, and eyecare professionals are not labelers, and therefore are not responsible for meeting UDI requirements for these devices.”
On September 24, 2013, the FDA instituted its final regulations to implement a UDI system in the United States. UDI applies to all medical devices including Class I medical devices (such as eyeglass frames, sunglasses, reading glasses, and many low vision devices). Unless exempted, Class I medical devices will be required to comply with the UDI regulations as of September 24, 2018. For most of The Vision Council’s members, the UPC code will suffice as the UDI per the FDA guidance.
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