UDI Extension for Soft Contact Lenses

Effective March 30, 2017, FDA is granting an extension for labelers of soft (hydrophilic) contact lenses to comply with the requirements of the Unique Device Identification (UDI) system. The extension states, “Therefore, pursuant to 21 CFR §801.55(d), FDA grants to labelers of the devices listed … an extension of the requirements to provide a unique device identifier (UDI) on the device label and packages, format dates on the device label according to 21 CFR §801.18, and submit data to the GUDID until one year after FDA 1) develops and fully integrates the Technical Solution into the GUDID production system, 2) provides any necessary updated technical specifications to affected labelers, and 3) notifies industry that the extension will expire, through emails to industry, communication via trade associations, and via the UDI website.”

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM550122.pdf