FDA Unique Device Identification (UDI) Overview

Presentation on UDI for Grace College Orthopaedic Regulatory and Clinical Affairs graduate program (RCA5700)

1. Unique Device Identification Caroline Bloemker Megan Klingler RCA 5700

2. History Section 226(a) 7/9/2012 – FDASIA (Food and Drug Administration Safety and Innovation Act (Public Law 112-144)) was signed into law 7/10/2012 – FDA published proposed rule to establish a unique device identification system FDA Amendments Act of 2007 (Public Law 110-85) created section 519(f) of the FD&C Act (21 USC 360i(f)) “The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier…” Section 614 FDASIA Section 614 of the FDASIA amended section 519(f) to implement a UDI System no later than 12/31/2012, and for medical devices to bear UDI no later than 2 years after regulations were finalized Specifies date of proposed rule, time-frame for publication of final rule, and identifies particular devices as requiring expedited implementation for devices that are implantable, life-saving, or life-sustaining FDA UDI Final Rule The final rule implements the above provisions requiring: A UDI to appear on the label and on the package of affected medical devices and establishes a GUDID (Global UDI Database) requiring device labelers to submit descriptive information about each version or model of device labeled with a UDI to the GUDID Builds on international regulatory cooperation activities by IMDRF (International Medical Device Regulatory Forum) member countries

3. Purpose Benefits of UDI include Adverse Event Reports – problem devices identified quickly Medical Errors – reduced since HCP’s have more device information Clinical Reporting – standard device usage reporting, robust Post-market Surveillance for new devices/uses Device Recalls – easier to manage Supply Chain – foundation for global, secure distribution chain Global Standard – leads to a global ID system for medical devices Scope Labels: what are you going to add to your label? Direct Part Marking: what you need to add to your device? Systems: how are you going to store this information?

4. Definitions UDI: Used by FDA and others for the regulation itself GTIN : Global Trade Item Number, signifies the new identifying part number under UDI

5. 21 CFR 830 New regulation

6. Issuing Agencies Issuing agencies are global organizations GS1 HIBCC (Health Industry Business Communications Council) ICCBBA (International Council for Commonality in Blood Banking Automation)

7. Example UDI Compliant Label

8. Global Unique Device Identification Database (GUDID) DI is submitted to GUDID database (not PI) Contains all data elements required by 21 CFR 830.310 Name of the labeler Telephone number or email of device identification contact Issuing agency Device identifier portion of UDI assigned to model Previous device identifier if a substitution has occurred If regulation requires UDI marking on device itself: A statement that DI is identical to DI reported The proprietary, trade, or brand name of the device as it appears on its label Version or model numbers that appear on its label Sterility statement if labeled as sterile Statement if labeled as including natural rubber latex that contacts humans Magnetic resonance statement Size with unit of measure Type of PIs that appear on label FDA premarket submission number, or statement that FDA has exempted device by regulation from premarket notification FDA listing number assigned to device Global Medical Device Nomenclature (GMDN) term or code Total number of individual devices in package

9. Implementation Dates 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 FDA enacts regulation Class III devices Class II FDASIA listed devices Class II non-FDASIA listed devices Class I devices Implants Software Instruments Everything else Date from when newly produced devices must conform to package label & attribute data Date for direct part marking Date from when all unsold devices must conform Note: All conformance dates are 9/24/XX High risk implants and life sustaining Dates on labels must be formatted as YYY/MM/DD Data for devices must be submitted to GUDID

10. http://medicaldeviceacademy.com/6-udi-implementation-deadlines-need-remember/

11. UDI UDI = DI + PI (GUDID Guidance) DI: Primary key, can be used to look up information about the device in the GUDID UDI of class I device is not required to include a PI Class I device that bears Universal Product Code (UPC) on its label and device packages has met UDI labeling requirements Class I devices that FDA has exempted by regulation from GMP requirements do not require UDI (21 CFR 801.30(a)(2)

12. Device Identifiers (DI) A mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device

13. Production Identifiers (PI) “a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device, unless excepted: The lot or batch number within which a device was manufactured The serial number of a specific device The expiration date of a specific device The date a specific device was manufactured And, for an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c)” 21 CFR 1271.290(c) requires that the manufacturer of each HCT/P assign and label it with a distinct identification code that allows the manufacturer to relate the HCT/P to the donor and to all records pertaining to the HCT/P. The distinct identification code may take the form of a donation identification number, serial number, lot number, or a combination of these production identifiers. (GUDID Guidance)

14. References http://www.hibcc.org/udi-resources / http:// www.gs1us.org/industries/healthcare/gs1-healthcare-us/fda-udi https:// www.iccbba.org/home 21 CFR 820, 830 www.ecfr.gov http:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm