Class II UDI Compliance Deadline Approaches

Today FDA released the DRAFT FDA guidance "Unique Device Identification System: Form and Content of the Unique Device Identifier."  While FDA's final rule was passed September 24, 2014, this is their first guidance on the subject.

This, and its final draft, is a must read for all medical device regulatory professionals.   It's time to update your Labeling SOPs. 

Links from the guidance brought me to the Compliance Dates for UDI Requirements page, found here. 

Importantly, this September 24th, 2016, manufacturers of Class II medical devices must be in compliance with the rule and begin labeling with UDI. 

FDA-Accredited Issuing Agencies are able to help manufacturers put in place the systems required to appropriately label per the UDI rule.

For help with your Class II UDI, visit the Contact page and send me a note.