Rx Lenses Exempted from UDI Requirements
On behalf of our member companies, The Vision Council began a direct dialogue with US Food and Drug Administration (FDA) in August of 2015 related to the Unique Device Identifier (UDI) issue. 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.
As a result of advocacy brought forward by The Vision Council, the FDA has exempted optical lenses from the scope of the UDI regulations. In a letter dated April 3, 2017, the FDA 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 labeler of each device is responsible for meeting the labeling and data submission requirements in the UDI System rule. Based on the information you provided to FDA and FDA’s current interpretation of the FD&C Act and its implementing regulations, prescription lens manufacturers, optical laboratories, and eye care professionals are not labelers, and therefore are not responsible for meeting UDI requirements for these devices.“
The Vision Council would like to commend the FDA for its decision related to ophthalmic lenses and UDI. We appreciate the FDA’s thoughtful questions and dialogue to find an appropriate solution for the ophthalmic lens industry. The Vision Council would also like to thank its members of the Mass Lens Manufacturers and the Government and Regulatory Affairs Committees, Technical Director Michael Vitale, Regulatory Affairs Counsel Rick Van Arnam, and our federal affairs representatives from Bryan Cave and Associates for their strong commitment and leadership in deliberating on this important issue.
Issue Background: on September 24, 2013, the FDA promulgated 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. 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.
Questions? Please contact The Vision Council Senior Technical Director Michael Vitale at firstname.lastname@example.org or Rick Van Arnam, The Vision Council Regulatory Affairs Counsel at email@example.com.