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Vision Council Member Webinars

Exclusively for members, 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. Bookmark this link for future event registrations and information.

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

Update: December 2, 2022

The Vision Council has continued to work with the FDA to clarify whether sunglasses and readers need to report under the GUDID by the December 8, 2022 deadline.

After back and forth conversations, the FDA has now confirmed that they do not consider medical devices captured under 21 CFR parts 801, subpart H as ‘Restriced Devices’ for purposes of the GUDID Guidance Document, published July 25, 2022.

Therefore, sunglasses and readers are within the express definition of consumer health products as per the guidance document and are relieved from having to report into the GUDID.

For complete information, please visit the Government Relations and Regulatory Affairs website here. Please feel free to direct all questions to Omar Elkhatib, The Vision Council’s Government Relations Manager, at [email protected]