The Vision Council Membership Portal
The Vision Council is a member-driven organization with a mission to promote growth in the vision care industry through education, advocacy, consumer outreach, strategic relationship building and industry forums.
Vision Council Member Webinars
Exclusively for members, please register below for recorded presentations covering the latest updates on UDI related topics. Reed Tech frequently provides free webinars on topics related to UDI and product data management topics. Register for the first event and receive an invite for subsequent events. Even if you can’t make the date, go ahead and register to receive the on-demand recording link.
Eyewear Industry Specifics: US FDA Class I UDI Submissions
August 23, 2022 / 11am ET
Reed Tech Life Sciences will give a presentation on US FDA Class I UDI requirements and exceptions, focusing on eyewear industry specifics and guidance communicated by leadership at The Vision Council.
On Friday, July 22, 2022, the U.S Food and Drug Administration (FDA) issued their final guidance on GUDID exceptions for Class I ‘consumer health products.’
By the FDA’s regulations, any medical device subject to impact resistance testing is a ‘restricted device.’ Thus, all eyewear devices with lenses that are required to pass the drop ball test are considered restricted devices by the FDA (see chart below for specific coding). This means that Plano, or non-prescription sunglasses and OTC readers are not ‘consumer health products’ and will need to comply 100% with UDI – labeling (using UPC codes if you so choose) AND GUDID reporting.
Register to attend live or on-demand to learn more. The UDI submission date is now December 8, 2022.
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