Class III devices – 12 months after publication of final rule – September 24, 2014
• Direct part marking due September 24, 2016
Implants & life sustaining/supporting devices – 24 months after publication of final rule –
September 24, 2015
• Direct part marking due September 24, 2016, if applicable.
• For devices delivered non-sterile in sets that are sterilized by the hospital before
use, providing UDI information to the point of final use is due September 24,
2016 (per FDA communication on 11/19/2014 entitled, “Dear Non-sterile Ortho
Set Labelers 11-18-2014 FINAL.pdf”).
Class II devices – 36 months after publication of final rule – September 24, 2016
• Direct part marking due September 24, 2018
Class I devices – 60 months after publication of final rule – September 24, 2018
• Direct part marking due September 24, 2020
Existing Inventory – The FDA provides a period of three (3) years for devices that have
been manufactured and labeled prior to the compliance date that applies to that device.
