Representing Unique Implantable Device Identifiers

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Type Standard Implementation/Specification Standards Process Maturity Implementation Maturity Adoption Level Federally required Cost Test Tool Availability
Standard
Final
Production
Rating 1
Yes
Free
N/A
Implementation Specification
In Developement
Pilot
Rating 1
No
Free
N/A
Limitations, Dependencies, and Preconditions for Consideration Applicable Value Set(s) and Starter Set(s)
  • Per the FDA, Unique Device Identification system will be phased in over several years, with the final compliance date of September, 2020.
  • Compliance date for UDI of implantable, life supporting and life sustaining devices was 9/24/2015.  These data are available at http://accessgudid.nlm.nih.gov.
  • The HL7 Harmonization Pattern for UDIs is currently in development, with the next revision release anticipated in February 2018.
  • See UDI projects in the Interoperability Proving Ground.
  •  Feedback requested