What is the FDA UDI? Appearing in two forms* : Easily readable - - PowerPoint PPT Presentation

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Dec 06, 2023 108 likes •216 views

What is the FDA UDI? Appearing in two forms* : Easily readable plain-text , and Automatic identification and data capture or AIDC technology Composed of two parts : Device Identifier or DI - mandatory, fixed, identifies the labeler and

SLIDE 1

What is the FDA UDI?

Appearing in two forms*:

Easily readable plain-text, and
Automatic identification and data capture or AIDC technology

Composed of two parts:

Device Identifier or DI - mandatory, fixed, identifies the labeler and the specific version
r model of a device; and
Production Identifier(s) or PI – conditional, variable identifies one or more of the

following when included on the label of a device:

 lot or batch number  serial number  expiration date  date manufactured  for an HCT/P (Human Cell, Tissue or Cellular or Tissue-Based Product) regulated as a device, the International Council for Commonality in Blood Banking Automation (ICCBBA).

For all exceptions refer to UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 2

PI & DI: Using GTINs

GTIN (Global Trade Item Number) Uniquely identifies the product.

Production Information (Lot, Expiry, etc.)

(This label is intended to depict GS1 standards. It is not yet compliant with UDI regulations.)

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 3

FDA UDI Rule Overview

Label with AIDC (barcode)
UDI=Device Identifier(DI)+Production Identifier(PI)
UDI=GTIN + Standardized Production Data
Label plain-text ISO format date YYYY-MM-DD

MARK

Publish UDI plus required data attributes to the Global

UDI Data Base (GUDID)

GDSN is one mechanism to publish that data once to

both the FDA and customers

SUBMIT

Year 1 (2014):Class III and devices licensed under PHS Act
Year 2 (2015):Class II/I implants and life-supporting/sustaining
Year 3 (2016):Remainder of Class II
Year 5 (2018):Class I
For Direct Marking- Compliance dates are extended by 2 years except for FDASIA

implants and life-supporting/sustaining

COMPLY

UDI Final Rule Sept 24, 2013 GS1 US website: www.gs1us.org/hcudi FDA UDI Website: www.fda.gov/gov and click on “UDI Help Desk”

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 4

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 5

Issuing Agencies

The UDI will be created and maintained by device

labelers based on global standards managed by FDA- accredited Issuing Agencies.

Issuing Agencies are:
GS1
HIBC
ICCBBA

UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 6

“Labeler means: (1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and (2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, except that the addition

f the name of, and contact information for, a person who distributes the

device, without making any other changes to the label, is not a modification for the purposes of determining whether a person is a labeler.”

Labeler Definition

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 7

UDI Date Format

YYYY-MM-DD

Dates on medical device labels for the user
Must conform to a standard format consistent with

international standards as year-month-day (for example, 2013- 09-30). In the event of an expiration in particular month, the labeler may choose the last day of the month for the date field.

Implementation Timeline - By UDI compliance date; if not – year 5

UDI Final Rule www.fda.gov/udi

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 8

General Exemptions

Source: Jay Crowley, “Not IF – but HOW… FDA’s Unique Device Identification (UDI) System –The Final Regulation.” September 23, 2013

Key Points:

FDA listened to stakeholders in

creating exemptions.

FDA has not yet posted the

exemptions that have granted post-UDI rule.

Some general exemptions are

complicated and will require additional discussion for a better understanding.

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 9

Repository of key device information.
Contains ONLY the DI, which serves as the primary key to
btain device information in the database and on the label. It

also flags which PI attribute(s) are on the label.

The data elements described in the UDI Final Rule are

included in the GUDID, consistent with their label plus data used to develop and maintain the GUDID, as well integrate with internal FDA systems.

Will be available to the public via the internet.

FDA Global UDI Database (GUDID)

UDI Final Rule www.fda.gov/udi and FDA GUDID Guidance for Industry dated June 27, 2014 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM369248.pdf

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago

SLIDE 10

Example of Elements from GUDID

Presented by E Fields, FDA at GS1 Connect 6-11-2014

2014 Fall Conference December 9 – 11, 2014 OMNI Hotel, Chicago