UDI for Class I Devices

Note: This blog reproduces some FDA website text

Do you have a Class I medical device and are you wondering if you need a Universal Device Identifier? The FDA will enforce UDI requirements for labeling, direct marking, Global Unique Device Identification Database (GUDID) data submission and standard date formats on September 24, 2022, just four months from now! If you have not started working on your UDI tasks, you may have some lead time issues. Vision28 can help you meet FDA’s deadline.

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What does this mean for YOUR device?  

        • If your device is GMP Exempt, then you do not need to worry about UDI requirements.

        • If your device is NOT GMP Exempt and if you have a UPC symbol on the device label and the device package, then you comply with the UDI labeling requirement.

        • If you don’t have a UPC, and are using a UDI symbol, then you only need the device identifier segment which identifies the device and device model; you do not need a production identifier segment.

        • If your device is intended to be reprocessed, then you need to have the UDI device identifier segment or UPC directly marked on the device.

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See a brief flowchart below.

Vision28 can help you use the flow chart to determine your device's UDI needs and we can document the decisions you make regarding your device by directly referencing the pertinent paragraphs in the regulation, so that when FDA inspects your facility you have a formal defense for your actions. We can also help you enter your data into the GUDID database.

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The Global Unique Device Identification Database

The GUDID (pronounced "Good ID") database contains device identification information about medical devices that have Unique Device Identifiers (UDI). The database helps the FDA identify devices sold in the U.S. from manufacturing through distribution to patient use. You can use the database to search for specific medical devices or download all the GUDID data at once.  

Drugs are identified by the FDA using the National Drug Code Directory (NDC directory). The NDC is a unique 10-digitor, 11-digit, 3-segment number, and a universal product identifier for human drugs in the United States. The first set of numbers in the NDC identifies the labeler, such as the drug manufacturer, repackager, or distributer. The second set of numbers is the product code, which identifies the specific strength, dosage form and formulation of a drug. Finally, the third set is the package code, which identifies package sizes and types.

UDI is a universal device (product) identifier for medical devices for human use in the United States. Like the drug NDC number, the UDI number is a unique identifier that clearly distinguishes one product from another. UDI is intended to provide a standard way to identify medical devices throughout their total product lifecycle.

Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself. Device companies must also submit certain information about these devices to the GUDID database.

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Universal Device Identifier

A UDI is composed of two parts:

Device Identifier (DI) - A unique numeric or alphanumeric code specific to a device version or model.  

Production Identifier(s) (PI) - Numeric or alphanumeric codes that identify production information for a device and can include the following:

        • The lot or batch number

        • The serial number

        • The expiration date

        • The date the device was manufactured

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Therefore, UDI = DI + PI.

UDI symbols are created based on international standards for unique identification. Private organizations, called "Issuing Agencies", are accredited by the FDA to operate a system for the issuance of UDIs based on these standards. A unique device identifier (UDI) on a device label appears in both plain text and in machine-readable format. Below is an example of a unique device identifier (UDI) from GS1, one of the FDA-accredited issuing agencies.  It uses a 1D barcode for its machine-readable format.

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Human Readable Barcode:

(01)12345678901234(17)140102(11)100102(10)A1234(21)1234

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In GS1's system, the numbers in the parentheses indicate the different parts of the UDI.

Device Identifier (DI) - 12345678901234

Production Identifiers (PI):  

        • Expiration Date: 140102  

        • Manufacturing Date: 100102

        • Lot Number: A1234

        • Serial Number: 1234

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Vision28has helped our clients find an FDA-accredited issuing agency, define the DI and PI for the UDI, and design UDI compliant labeling.    

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Flow Chart for Class I Device