FDA has made changes to HL7 SPL Implementation Files, which will be included in the upcoming GUDID Release 1.2.1. Updates include updating the GUDID pre-production environment (by end of April 2014 and production environment by beginning of May 2014.
Other changes include the addition of a new Production Identifier called Donation Identification Number (DIN). This is for packages managed by a DIN. The DIN is for regulated devices that are also Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P). This is a required attribute.
MRI Safety Status has been combined into one question. New values have been added to the Sterilization Method attribute. There are also additional values for Size Type and Unit of Measure.
For complete details, visit the FDA GUDID Website.
For questions you may have on UDI Final Rule, please visit my FAQ blogs, Part 1 and 2
Part I - http://bit.ly/UDIfinal
Part 2 - http://bit.ly/UDIfinpt2
FDA UDI Regulation’s Impact on Medical Device Labelers-audio recording and powerpoint training presentation