UDI Introduction Dennis Black Director, e-Business BD In the - - PowerPoint PPT Presentation

UDI Introduction Dennis Black Director, e-Business BD

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

In the following eleven slides, Dennis Black does a masterful job of explaining the many facets of UDI

UDI Requirements – Overview

• The following is a high level
• verview of the FDA UDI Regulation.
• You will not be an expert on UDI

after this review and should review the Federal Register for a complete review of the regulation and consult your legal counsel.

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

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).

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

PI & DI: Using GTINs

DI

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

PI

Production Information (Lot, Expiry, etc.)

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

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

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

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

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

“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

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

General Exemptions

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

• 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)

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

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