FDA Extends UDI Deadline For Class I Devices

FDA Extends UDI Deadline For Class I Devices

06/06/2017

On June 2, 2017, the U.S. Food and Drug Administration (FDA) issued a letter stating its intent to extend by two-years the Unique Device Identifier (UDI) compliance deadline date for Class I and unclassified medical devices.  According to the letter, the FDA will issue a guidance document in which it will exercise its enforcement discretion to push off the upcoming September 24, 2018 compliance deadline. The new compliance deadline will now be September 24, 2020. This action will not apply to Class I devices and unclassified devices that are life supporting or sustaining, as labelers of those devices must already comply with the UDI requirements.

“This is welcomed news for The Vision Council members, whose products typically fall within the Class I designation,” said Fredric Grethel, Chair, Government & Regulatory Affairs Committee. “For example, eyeglass frames, prescription lenses, plano sunglasses, reading glasses, and many low vision devices, are FDA Class I devices. The Vision Council has closely partnered with the agency on this issue and is thrilled to be able tell members that they now have an additional two years to implement UDI and GUDID-reporting compliance programs as a result.” 

Please note that this action does not affect the recent exemption granted by the FDA to prescription lens manufacturers and optical laboratories, whereby prescription lenses were exempted from UDI compliance.  

Please contact Rick Van Arnam, The Vision Council’s regulatory counsel, or Michael Vitale, The Vision Council’s technical director, with questions or requests for more information.

Categories: 
Government and Regulatory Affairs
Divisions: 
Sunglass & Reader Division
Lab Division
Lens Division
Lens Processing & Technology Division
Low Vision Division
Eyewear & Accessories Division