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FDA’s Global Unique Device Identification Database (GUDID)

Jay Crowley Senior Advisor for Patient Safety

Food and Drug Administration jay.crowley@fda.hhs.gov

301-980-1936

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GUDID – Account and User Roles

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Global UDI Database For each Device Identifier: • Manufacturer (DUNS), Make/model, Brand/Trade • Device version/mode/catalogue/reference numbers • Clinically relevant size • Contact information • Sterility information; Contains latex; Single-use • Controlled by – Lot and/or Serial Number; Exp. Date • FDA premarket authorization (510k, PMA); listing # • GMDN PT; FDA product code (procode) • Marketing Status/date • Higher levels packaging • Kit; combination product; Rx/OTC; HCT/P

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GUDID – DI Elements • Issuing Agency – organization accredited by FDA to

operate a system for the issuance of UDIs. • Primary DI Number – an identifier that is the primary

lookup. Located on the base package, which is the lowest level of a medical device containing a full UDI.

• Secondary DI – another DI issued from a different issuing agency

• Unit of Use DI Number – an identifier assigned to associate the use of a device on a patient. For use when a base package contains more than one device.

• DM DI Number – an identifier marked directly on the medical device and is different than the Primary DI.

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GUDID – Name Elements • Brand Name – the proprietary, trade, or brand name of

the medical device as used in device labeling. • Model/Version Number – the model or version number

found on the device label or accompanying packaging. • Catalog Number – the catalog, reference, or product

number found on the device label or accompanying packaging to identify a particular product.

• Device Description – additional clinically relevant information about the device that is not already captured as a distinct GUDID data attribute.

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GMDN Each GMDN Term consists of 3 parts: • Preferred Term Name: Insulin syringe, fixed-needle • Definition: A device consisting of a small, calibrated,

hollow barrel (cylinder) and a moveable plunger with a permanently-attached needle (usually capped for user protection) that is used to administer an injection of insulin to a patient subcutaneously…

• Code: 38501

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DI Record Status State Description System Save Possible actions

Draft DI record

Saved DI record that has not passed business rules

--purged after 180 calendar days; -- if edited and resaved as draft, 180 day cycle resets and starts over

- Unlimited Editing - Resave as Draft - Delete Draft - Must pass business rules to move states

Unpublished DI record

DI record that has passed business rules AND Publish Date > today

Saved indefinitely - Copy - Unlimited Editing - Publish (when Publish Date = today)

Published DI record

--DI record that has passed business rules AND Publish Date <= today

Saved indefinitely - Copy - Limited Editing per Grace Period Rules [Cannot be unpublished w/out FDA intervention]

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DI Record Life-Cycle

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Editing Un/Published DI Records

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Packaging Hierarchy

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FDA’s Global UDI Database

Distribution

Web based tool

Business Rules

Manufacturer (Acme)

3rd Parties (GDSN)

The label of Medical Device 123 Size 45: Device Identifier (Device XYZ123) Production Identifier (Lot #ABC) Expiration date (MMDDYYYY)

Sterile; Latex free

Bulk HL7 SPL

Minimum Data Set For each Device Identifier: • Manufacturer and model • GMDN Code • Other attributes

or

or

FDA’s UDI Database

FDA

FDA Managed

Public User Interface

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GUDID Draft “User’s Guide” • Publish draft “user’s guide” in May • Explain how interaction with the database will work:

• Organizational module (DUNS structure, DUNS – match label, various user roles)

• Device Identifier module/life-cycle, published records, grace period

• Both web-base (UI) and HL7 SPL • Search

• Comments welcome • Future training and database access

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UDI Application Example

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UDI Application Example

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UDI Application Example

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UDI Application Example

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ISBT128 Device Identifier (Static): A9997T9017Z012 • A9997 is the processor identifier assigned by ICCBBA ≡

manufacturer identifier • T9017Z012 is the product identifier ≡ catalogue number Production Identifier: A999912123456102 • A999912123456 is the donation identification number ≡

Lot no. • 102 is the division number ≡ serial number

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Unique Device Identification www.fda.gov/UDI UDI@fda.hhs.gov

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