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FDA Exempts Optical Lenses From Unique Device Identification (UDI) Labeling Requirements

The Food and Drug Administration (FDA) has exempted optical lenses from the scope of its Unique Device Identifier (UDI) regulations, according to an announcement Tuesday by The Vision Council.

The Vision Council noted that it received a letter from the FDA dated April 3, which stated that the agency “concurred with The Vision Council that lens manufacturers, optical labs and eyecare providers are not subject to the UDI’s labeling and reporting requirements.”

The Vision Council, through both written correspondence and in-person meetings with FDA staff, had advocated for optical lenses to receive an exemption from the labeling regulation, first promulgated in 2013. “Because of the complex nature of prescription lens manufacturing, The Vision Council sought to gain an exemption from this regulation citing that prescription lenses are custom devices and that lens producers are not labelers per the FDA regulations,” the Vision Council said in its announcement.

In its letter, FDA concurred with The Vision Council’s position that lens manufacturers, optical labs and eyecare providers are not subject to the UDI’s labeling and reporting requirements.

“The labeler of each device is responsible for meeting the labeling and data submission requirements in the UDI System rule,” the FDA’s letter explained. “Based on the information you provided to FDA and FDA’s current interpretation of the [Food, Drug & Cosmetic 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.”

The UDI exemption under Class 1 medical devices was among the issues that The Vision Council raised with members of Congress during its annual “Capitol Hill Fly-In” back in 2015, as VMail reported.

In its announcement on Tuesday, The Vision Council said it commended the FDA for its decision related to ophthalmic lenses and the labeling requirements. “We appreciate the FDA’s thoughtful questions and dialogue to find an appropriate solution for the ophthalmic lens industry,” The Vision Council noted.

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