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Unique Device Identification (UDI): Implementation and Adoption

Unique Device Identification (UDI): Implementation and Adoption. Leslie M Tompkins, PhD FDA, Center for Devices and Radiological Health UDI Lead, Standards and Vocabularies HL7 Working Group Meeting, Phoenix May 2014. Basics of the UDI Rule. 21 CFR 801.20

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Unique Device Identification (UDI): Implementation and Adoption

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  1. Unique Device Identification (UDI): Implementation and Adoption Leslie M Tompkins, PhD FDA, Center for Devices and Radiological Health UDI Lead, Standards and Vocabularies HL7 Working Group Meeting, Phoenix May 2014

  2. Basics of the UDI Rule • 21 CFR 801.20 • …the label of every medical device shall bear a unique device identifier (UDI)… • 21 CFR 830.300 • …the labeler of a device must provide the information required … for each model or version required to bear a unique device identifier (UDI)…

  3. Where we are… • January 2014 • GUDID release 1.1 • March 2014 • GUDID release 1.2 • April 2014 • HL7 SPL IG r1.2 • September 2014 • Class III Compliance Date • September 2013 • 78 FR 58786 (UDI Rule) published • GUDID Draft Guidance published • GUDID production goes live • UDI Helpdesk goes live • November 2013 • HL7 SPL Implementation Guide published

  4. Where are we… • Helpdesk • >1400 questions received • Answered: • 711 Regulatory • 599 Technical • 15 Data Quality • www.fda.gov/udi • GUDID • 80 records submitted (unpublished state) • Dozens of draft records • Accounts • 71 production • 32 pre-production (SPL testing) • 10 Third-party

  5. Adoption of UDI into Health IT • Harmonization of UDI representation across HL7 documents and messages • NPRM 2015 Certification Criteria for EHRs • PROPOSED: Meaningful Use, Stage 3 • …should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted device.

  6. UDI Resources UDI website - www.fda.gov/UDI • UDI Help Desk • Sign up for UDI alerts • GUDID Draft Guidance • Appendix B – Vocabulary • Appendix C - UDI Specifications by Issuing Agency Strengthening our National System for Medical Device PostmarketSurveillance -http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf HL7 UDI Task Force http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force

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