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
1. Name of the labeler
2. Telephone number or email of device identification contact
3. Issuing agency
4. Device identifier portion of UDI assigned to model
5. Previous device identifier if a substitution has occurred
6. If regulation requires UDI marking on device itself:
1. A statement that DI is identical to DI reported
7. The proprietary, trade, or brand name of the device as it appears on its label
8. Version or model numbers that appear on its label
9. Sterility statement if labeled as sterile
10. Statement if labeled as including natural rubber latex that contacts humans
11. Magnetic resonance statement
12. Size with unit of measure
13. Type of PIs that appear on label
14. FDA premarket submission number, or statement that FDA has exempted device by
regulation from premarket notification
15. FDA listing number assigned to device
16. Global Medical Device Nomenclature (GMDN) term or code
17. 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-

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/DeviceRegulatio
nandGuidance/UniqueDeviceIdentification/GlobalUD
IDatabaseGUDID/default.htm