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 3, 2017, click here to view the letter from the FDA.

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.