Unique Device Identifier (UDI) Regulations and News

Any questions about this issue can be directed to Rick Van Arnam, The Vision Council's regulatory affairs counsel, at rvanarnam@barnesrichardson.com, or to Michael Vitale, The Visions Council's Senior Technical Director and Lens, Lab and LPT Division Liaison, at mvitale@thevisioncouncil.org.

FDA Extends UDI Compliance Deadline for Class I Devices by Two Years

The U.S. Food and Drug Administration (FDA) has announced it will extend the current enforcement moratorium on Unique Device Identifier (UDI) labeling and reporting requirements an additional two years, making the new deadline September 24, 2022. This provides all companies involved with class I medical devices additional time to implement their UDI compliance programs.

This announcement follows The Vision Council's formal request to the FDA several months ago requesting an extension for the existing UDI enforcement moratorium. The Vision Council's request letter cited the impact of the COVID-19 pandemic on the industry as the basis for the requested extension of the upcoming deadline. A copy of The Vision Council's letter to the FDA can be found here.

Pursuant to the moratorium, the FDA will not enforce UDI labeling, standard date formatting or GUDID data submission for all class I medical devices until September 24, 2022. Class I devices include spectacle frames, Plano sunglasses, over-the-counter reading glasses and many low vision devices. Prescription lenses are also class I medical devices and received exemption on April 3rd, 2017, click here to view the letter from the FDA.

Rx Lenses Exempted from UDI Requirements

On behalf of our member companies, The Vision Council began a direct dialogue with U.S. Food and Drug Administration (FDA) in August of 2015 related to the Unique Device Identifier (UDI) issue. Due to 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."

To read the full letter from the FDA, click here.

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.

UDI Guidance for the Sunglass and Reader, Eyewear and Accessories, and Low Vision Divisions

The Vision Council has prepared a special UDI guide for members of the Sunglass and Reader, Eyewear and Accessories, and Low Vision Divisions. Download the latest version of the guide here. For more information on the UDI system, click here.

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.