FDA UDI & GS1

To meet UDI requirements, companies may follow one of three standards systems: GS1, HIBCC, and ICCBBA.

The GS1 system has emerged as a front-runner thanks largely to its already global reach and adoption in a number of overlapping markets. The standards cover the formatting, dimensions, and print quality for barcode symbols carrying UDI data, as well as the numbering system used to uniquely identify devices and the data formatting for relevant data fields.

One of the most common GS1-related barcodes is the UPC.  This is used to identify retail products throughout the world.  It is already in use on many medical devices that are sold in a retail setting.


upc-sample

The two other common GS1 barcodes used in UDI are the GS1-128 linear barcode and the GS1 Data Matrix 2D barcode (Learn more about linear vs. 2D here):

gs1-data


data-matrix-data

As a GS1 Solution Provider with a number of GS1 Certified Professionals and GS1 Certified Consultants on staff, Identification Labs can assist companies with barcode and packaging certification, data validation, and data migration.

 

FDA UDI Mandate

Starting in 2014, and concluding in 2018, all medical devices must follow FDA UDI requirements.

There are two components to the FDA UDI requirements.

  • Maintain device information in central database hosted by the FDA.
  • Comply with UDI Device Marking guidelines for all devices.

device-data-marking-relationship-300x244

Both of these components work together to ensure accurate identification and traceability of medical devices.

Responsibility for meeting these requirements fall on what the FDA has defined as the “labeler”.  Specifically, this is the “the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.”

To comply, the FDA has recognized several acceptable standards: GS1, HIBCC, and ICCBBA.  While each standard is different, they all share the ability to convey required UDI data in standardized data formats and standardized barcode formats.

 

FDA UDI Timeline for Implementation

On September 24, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that established the need for the Unique Device Identification (UDI) System. Soon after the UDI System was signed into law as part of the Food and Drug Administration Amendments Act of 2007, the FDA was called to publish a timeline for the UDI implementation.

FDA timeline based on the risk class of the devices

  • 1 year after issuance of final rule – Class III devices
  • 2 years after issuance of final rule – Class II implants and life-supporting/life-sustaining devices
  • 3 years after issuance of final rule – Remaining class II devices
  • 5 years after issuance of final rule – Class I devices

September 24, 2014 – 1 Year after Issuance of Final Rule

  • A unique device identifier (UDI) will be required on all class III medical devices.
  • UDI data should be submitted to the Global Unique Device Identification Database (GUDID).
  • A 1-year extension can be requested latest by June 23, 2014.
  • UDI must be provided by class III stand-alone software

September 24, 2015 – 2 Years after Issuance of Final Rule

  • UDI must be present on class II life-sustaining & supporting and implantable devices.
  • For devices that are designed to be used more than once and/or require processing before every reuse, a permanent UDI marking on the devices themselves is required.
  • UDI must be provided by class III stand-alone software that is life-sustaining or life-supporting

September 24, 2016 – 3 Years after Issuance of Final Rule

  • A permanent UDI marking on the devices themselves is required in the case of Class III devices that are designed to be used more than once and/or require processing before every reuse.
  • A UDI must be present on the packages and labels of class II medical devices. The UDI data should be submitted to the GUDID.
  • UDI must be provided by class II stand-alone software

September 24, 2018 – 5 Years after Issuance of Final Rule

  • A permanent UDI marking on the devices themselves is required in the case of Class II devices that are designed to be used more than once and/or require processing before every reuse.
  • A UDI must be present on the packages and labels of class I medical devices.
  • UDI must be provided by class I stand-alone software
  • UDI must also be present on devices not yet classified into class I, class II, or class III. The UDI data should be submitted to the GUDID.

September 24, 2020 – 7 Years after Issuance of Final Rule

  • A permanent UDI marking on the devices themselves is required in the case of devices that have not been classified into class I, class II, or class III and are designed to be used more than once and/or require processing before every reuse.

The implementation timeline is generally perceived as quite lengthy. Patients will have to wait until 2020 to benefit from a system with a completely operational device tracking system. Nonetheless, the final rule brings the U.S. one step closer to a UDI system that improves adverse event reporting, among other things. According to research, UDI’s implementation will also translate into around $16 billion in savings per annum. These remarkable cost savings will be primarily driven by automation of previously manual processes as well as enhanced efficiencies across the medical system.

Linear vs. 2D Barcodes

Barcode size and its impact on device packaging has been a concern for a number of our UDI clients. The volume of data required for UDI means that a traditional linear barcode like the GS1-128 can take up significant space. This presents a big problem for companies with smaller packaging and companies that desire a cleaner package design. Fortunately the FDA UDI requirements allow for use of 2-dimensional (2D) barcodes. Compared to linear barcodes, 2D barcodes can encode all of the required UDI data fields in a significantly smaller area, allowing for easier integration into device packaging. The GS1 UDI implementation has several acceptable 2D symbologies, but we will look at the GS1 Data Matrix.

The example below demonstrates the size differences between a 2-dimensional GS1 Data Matrix barcode and a linear GS1-128 barcode that encode the same data. Examples assume properly formatted GS1 type symbols following GS1 acceptable sizing.

 

Size Differences

linear-size1


2D-size

 

Both of these barcodes encode a GTIN, Manufacture Date, Expiration Date, Lot Code, and Serial Number.  The linear barcode on the left, printed at 10 mils, measures 4.5″ wide x 0.5″ tall.  The 2D barcode on the right, printed at 12 mils, measures under 0.4″ wide x 0.4″ tall.

UDI Solutions

UDI Label Certification

All relevant UDI data fields must be encoded in a barcode on the device packaging or in some cases directly on the device. Identification Labs can assist companies that need to certify that their UDI barcodes and marking meet UDI requirements.  Our labs employs a variety of barcode verification devices, all GS1 certified, to evaluate barcode symbols.

Testing results provide a detailed analysis of any issues and provide easy to understand resolutions.  All results are backed by our qualified staff that can provide one-on-one support by phone, email, and web-conferencing.

Data assistance

A key component of the FDA’s UDI requirements is the development of Global UDI Database (GUDID).  The GUDID serves as a catalog for key device information.  Companies are required to enter this information into the GUDID as part of UDI compliance.

Identification Labs has extensive experience with this type of data migration and offers data assistance services for the validation and uploading of GUDID data.

  • UPC (GTIN-12)

  • ISBN/Books

  • Medical/UDI

  • Supply Chain

  • Assets/Inventory

  • Coupon

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UPC (GTIN-12)

There are a variety of different types of barcodes. However, the UPC (Universal Product Number) symbol is the most recognized barcode in the United States, since it appears on almost every retail product. The UPC symbol is the barcode representation of the GTIN-12 which consists of twelve numeric characters that uniquely identify a company’s individual product. The GTIN-12 number is part of the family of GS1 global data structures that employ 14 digits and can be encoded into various types of data carriers.

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ISBN/Books

A requirement for selling a book through booksellers, wholesalers, and distributors is the assignment of unique ISBN numbers for each title and for each book to be marked with a Bookland EAN barcode.

The Bookland symbol allows for encodation of ISBNs (the numbers publishers use to identify their products). Since an ISBN is unique to one particular title (or product), the corresponding Bookland EAN symbol is a title-specific marking which is unique for that title. For example, if a title is available in hard cover, soft cover and as an e-book, three unique ISBN Bookland EAN bar codes are required.

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Medical/UDI

The FDA UDI Mandate is part of a comprehensive healthcare traceability initiative to improve patient safety.  The Unique Device Identifier (UDI) requirement is rooted in holding each member of the supply chain responsible for ensuring each medical device is marked with a UDI barcode with data maintained on the FDA’s GUDID universal database.

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Supply Chain

Logistic barcodes such as the GS1-128 Shipping Label are used to track movement of a shipment within a supply chain.  Since suppliers are making shipments to a variety of trading partners it is essential to integrate the relevant standards and current technology.  The use of EDI and 2D barcodes which can encode much more data has transformed many supply chains.

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Assets/Inventory

The first step in designing an asset tracking system is to determine whether you are working with assets or inventory.  Assets are any items a company uses internally such as tools, equipment, furniture etc.  Inventory are items which are sold, distributed or used by a company.  The distinction between Assets and Inventory is essential in regards to how the items will be marked, scanned and stored.

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Coupon

The successful integration of GS1 DataBar Coupons has dramatically improved many promotions.  The interhent features including; value codes and automatic expiration date checking for retailers, has enabled more efficient redemption, much better security and better metrics to measure the performance of a campaign.

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