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
6. Issuing Agencies
Issuing agencies are global organizations
GS1
HIBCC (Health Industry Business Communications
Council)
ICCBBA (International Council for Commonality in
Blood Banking Automation)
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
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)
Everyone gets a piece of UDI! These three organizations are FDA-accredited to assign UDIs according to the final rule.
These are the FDA Mandated Deadlines for manufacturer submission of UDI information to the GUDID. When these dates come, you cannot sell product in the U.S. if not compliant. This could cost your company millions in sales if you’re not prepared.
9/24/2013 is when the GUDID Production System: UDI Website and UDI Helpdesk was implemented
1 year – 9/24/2014 is when the Class III devices had to be added to the GUDID (high risk implants and life sustaining)
2 years – 9/24/2015 is when Class II implants and life supporting/life sustaining devices have to be added to the database
3 years – 9/24/2016 is when the rest of the class II device have to be added to the database
5 years – 9/24/2018 is when Class I devices have to be added to the GUDID
UDI is composed of 2 parts – DI and PI – and is required to appear on the label of every medical device, and every device package, unless exempt
Human cells tissues and cellular tissue-based products