UDI Guidance for Frames, Sunglasses, OTC Readers & Low Vision
As reported on April 18, the FDA has exempted optical lenses from the scope of UDI regulations. However, as of this communication, other Class I medical device products (frames, sunglasses, OTC readers and certain low vision devices) will need to be compliant to the UDI regulation; scheduled to go into effect on September 24, 2018.
To assist our members, The Vision Council has issued a UDI Guidance Document designed for our Low Vision, Sunglass & Reader and Eyewear & Accessories members.
The Unique Device Identification system, known as the UDI, will be used to identify and trace medical devices through distribution and use. Labels of medical devices will include a UDI in human and machine readable forms, and UDI labelers must submit information into the FDA’s Global Unique Identifier Database (“GUDID”).
For a complete overview of UDI, please visit our Unique Device Identification System Final Rule and its Impact on Ophthalmic Industries guide. Please contact Michael Vitale, Technical Director, or Rick VanArnam, Legal Counsel for Regulatory Affairs with questions.