Ombu Enterprises LLC Ombu Enterprises LLC   
 
 
 
  UDI Compliance Data Extended

In a June 2, 2017 letter, FDA extended the compliance dates for Class I and unclassified devices. The compliance date for labels (including date format) and submitting data to GUDID is extended from September 24, 2018 to September 24, 2020. In addition, the compliance dates for direct marking these devices moves from September 24, 2020 to September 24, 2022.

 

The letter is available at https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM561575.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

 
 
 
 
© 2017 All Rights Reserved.