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.
- 12 Sep 2017HIN Distribution Files Available Online
- 03 Jul 2017HIN Distribution Files Available Online
- 05 Jun 2017FDA Extends UDI Compliance Deadline for Class 1 Devices
- 26 May 2017FDA Posts New Webpage on Use of Symbols in Labeling
- 07 Apr 2017European Parliament Votes to Adopt Medical Device Regulation Proposal