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)… 2

3. 3 UDI Phased Implementation Sept 24 2013 GUDID, UDI Website, and UDI Help desk Available 1 Year – Sept 24 2014 Class III devices 2 Years – Sept 2015 Implants and Life-Saving/Life-Supporting 3 Years – Sept 2016 Class II devices 5 Years – Sept 2018 Class I devices

4. Sept 2013 OctNovDec2014 JanFebMarAprMayJunJulAug Sept 2014 OctNov Where we are… 4 September 2013 –78 FR 58786 (UDI Rule) published –GUDID Draft Guidance published –GUDID production goes live –UDI Helpdesk goes live November 2013 –HL7 SPL Implementation Guide published January 2014 –GUDID release 1.1 March 2014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

5. 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questions received –Answered: 711 Regulatory 599 Technical 15 Data Quality www.fda.gov/udi GUDID –80 records submitted (unpublished state) –Dozens of draft records Accounts –71 production –32 pre-production (SPL testing) –10 Third-party 5

6. Adoption of UDI into Health IT 6 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.

7. UDI website - www.fda.gov/UDIwww.fda.gov/UDI –UDI Help Desk –Sign up for UDI alerts –GUDID Draft Guidance –Appendix B – Vocabulary –Appendix C - UDI Specifications by Issuing Agency Strengthening our National System for Medical Device Postmarket Surveillance - http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSur veillance/UCM348845.pdf http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSur veillance/UCM348845.pdf HL7 UDI Task Force http://hl7tsc.org/wiki/index.php?title=2013-11-21_TSC_UDI_Task_Force 7 UDI Resources