Unique Device Identification

Caroline BloemkerMegan Klingler

RCA 5700

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

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?

Definitions UDI: Used by FDA and others for the

regulation itself GTIN: Global Trade Item Number, signifies the

new identifying part number under UDI

21 CFR 830 New regulation

Issuing Agencies Issuing agencies are global organizations GS1 HIBCC (Health Industry Business

Communications Council) ICCBBA (International Council for

Commonality in Blood Banking Automation)

Example UDI Compliant Label

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 labeler2. Telephone number or email of device identification contact3. Issuing agency4. Device identifier portion of UDI assigned to model5. Previous device identifier if a substitution has occurred6. If regulation requires UDI marking on device itself:

1. A statement that DI is identical to DI reported7. The proprietary, trade, or brand name of the device as it appears on its label8. Version or model numbers that appear on its label9. Sterility statement if labeled as sterile10. Statement if labeled as including natural rubber latex that contacts humans11. Magnetic resonance statement12. Size with unit of measure13. Type of PIs that appear on label14. FDA premarket submission number, or statement that FDA has exempted device by

regulation from premarket notification15. FDA listing number assigned to device16. Global Medical Device Nomenclature (GMDN) term or code17. Total number of individual devices in package

Implementation Dates2013 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

SoftwareInstruments

Everything else

Date from when newly produced devices must conform to package label & attribute dataDate for direct part markingDate from when all unsold devices must conformNote: 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

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

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)

Device Identifiers (DI) A mandatory, fixed portion of a UDI that

identifies the labeler and the specific version or model of a device

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)

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