The FDA has extended the compliance date for UDI labeling and data submission requirements to September 24, 2018 for the class II devices listed below. All other class II devices are subject to the September 24, 2016 UDI compliance date.
- Collections of two or more different devices packaged together in which the devices in the package are not individually labeled.
- Repackaged single-use devices
To view the official FDA Extension Letter click here.
- 03 Jan 2017HIN Distribution Files Available Online
- 19 Oct 2016HIN Distribution Files Available Online
- 07 Sep 2016FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices
- 30 Aug 2016New Version of “Create a HIBC UDI & Bar Code” Utility Now Available
- 26 Jul 2016FDA releases draft guidance on UDI form and content