The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document is intended to provide additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to achieve and sustain compliance with the applicable regulatory requirements. At the same time, provisions of the guidance are non-binding. Hence, an alternative approach could be applied, provided such an approach complies with existing legislation and has been agreed with the authority in advance.
Table of Contents
Regulatory Background
Apart from other aspects related to ensuring the safety and effectiveness of any medical devices allowed to be marketed and used in the US, the FDA is responsible for establishing a unique device identification system intended to improve the traceability of medical devices. The present guidance is addressed to entities responsible for placing labels on medical devices and outlines the scope of information to be submitted to the Global Unique Device Identification Database (GUDID). The authority also mentions that the present document constitutes a final version of the respective draft issued earlier by the FDA and modified based on comments and suggestions received from industry representatives and other parties involved. The FDA also reserves the right to modify this guidance to reflect changes and amendments.
As it was mentioned before, the document is not intended to introduce rules and requirements, but to provide additional clarifications and recommendations that are non-binding.
Unique Device Identifier
According to the guidance, the unique device identifier (UDI) should be created and maintained by device labelers based on global device identification standards managed by FDA-accredited Issuing Agencies. For this guidance, labeler stands for any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any intended subsequent replacement or modification of the label; and, 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 of the name of, and contact information for, a person who distributes the device, without making other changes to the label, is not a modification to determine whether a person is a labeler. The three main agencies entitled to issue UDIs are GS1, HIBCC, and ICCBBA. The format of UDIs is prescribed by the appropriate documents issued by the FDA to introduce a standardized approach.
Under the general rule, a unique device identifier should be placed on the label of any medical devices allowed to be marketed and used in the US, as well as the packages thereof, except the cases when the device falls within the scope of an exemption. The authority explicitly states that this applies for all medical devices irrespectively of their type including, inter alia, in vitro diagnostic devices and stand-alone software. As it is further explained, a unique device identifier comprises of two elements:
- Device Identifier (DI) – a component that identifies the entity responsible for placing the label, as well as the particular model of the device. The authority also mentions that this element is mandatory.
- Product Identifier (PI) – a component that provides details about the batch/serial number of the product, production/expiration dates, and other information required. According to the guidance, this element is conditional.
The first element is the most important one, as it could be used to check for additional information regarding the device contained in the appropriate database.
Any other identifiers used for medical devices are falling outside the scope of the regulatory framework described herein.
It is also important to mention that in the case of low-risk medical devices assigned to class I under the applicable risk-based classification, the second element (PI) is not required. Moreover, for such devices, a Universal Product Code (UPC) could be used instead. Furthermore, if the class I device in question falls within the scope of the appropriate exemption from the good manufacturing practice requirements, the requirements related to a unique device identifier could be waived as well.
By the applicable regulatory requirements, entities responsible for placing labels are obliged to submit DI, together with additional information, to the respective global database, except the cases when this requirement is explicitly waived. In terms of the timeframes, the Agency states that the information should be updated within 15 calendar days from the date the new product model has been placed on the market and made available for customers.
Global Unique Device Identification Database
The guidance further explains the role of GUDID and outlines the scope of information to be contained therein. According to the document, the database should contain only the first element – the DI – used to get additional information about the device. In terms of PIs, the FDA explains that PIs are not submitted to or stored in the GUDID; the GUDID contains only production identifier flags to indicate which PI attribute(s) are on the device label unless excepted.
The scope of information the database should contain is prescribed by 21 CFR 830.310. Apart from this, the database could contain additional information necessary to ensure the effectiveness of information exchange. To assist the parties responsible for placing labels, the FDA provides references to the GUDID Data Element Reference Table which contains comprehensive information about the information the database entries should contain. The Agency additionally emphasizes that the information submitted to the database should match the information reflected in the respective labeling.
The FDA also describes the design principles GUDID development is based on. These principles include the following ones:
- Submission based either on manual data entry via the GUDID Web Interface or automated submission via XML files using the FDA Electronic Submission Gateway (ESG) – Health Level 7 (HL7) Structured Product Labelling (SPL) submission.
- Standards-based data repository with controlled vocabularies including:
- Dun & Bradstreet (D&B) Numbers (DUNS),
- Global Medical Device Nomenclature (GMDN),
- FDA Product Codes.
- Free and public access to the device information in GUDID via public search; download capability is planned for the future.
In summary, the present FDA guidance provides an overview of the core concepts related to unique device identifiers and respective databases. The document highlights the most important aspects to be considered by the entities responsible for placing labels on devices and packaging and also outlines the scope of their responsibilities in terms of submitting information for inclusion in the GUDID.
Sources:
https://www.fda.gov/media/86569/download
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