Innovation in Medical Device - Are You ready for UDI? | Page 3

FDA Unique Device Identification (UDI) System

Requirements and Expected Timeline
In the US, implementation will follow a risk-based approach over several years with the
highest risk devices taking effect one year after the final ruling is finalized. Lower risk devices
will be distributed over the subsequent years. A compliant UDI program needs to address
three areas: Label & Packaging, Direct Marking (DM) and a UDI Database.

Label & Packaging
•
•

•
•

UDI Database

Publishing of DI and
Publishing of DI and
product attributes to FDA
product attributes to FDA
database via direct portal
database via direct portal
entry or HL7/SPL standards
entry or HL7/SPL standards
for bulk uploads.
for bulk uploads.

Directly marking the DI
Directly marking the DI
as a permanent marking
as a permanent marking
on multi-use devices
on multi-use devices
intended to be reprocessed
intended to be reprocessed
prior to each use.
prior to each use.

Inclusion of UDI and
Inclusion of UDI and
barcode on label
barcode on label

•
•

Direct Marking (DM)

UDI = Device
UDI = Device
and Production
and Production
Identifier (DI) + (PI)
Identifier (DI) + (PI)

Labels on lowest level
Labels on lowest level
of packaging
of packaging

FDA Compliance Timeline
2013
UDI Database
Label &
Packaging

2014

2015

Class III

Class I-II**

2016

2017

Class II

2018

2019

2020

Class I

remainder
remainder

remainder
remainder

Class III

Class II

2013-09-24

Final FDA Rule
Direct
**
Marking **

Class I

* Implantables and Life-sustaining / Life-supporting
** Multi-use devices that are intended to be reprocessed before each use

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