Posted 10 June 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) has finalized a guidance document intended to outline the appropriate use of its Global Unique Device Identification Database (GUDID), an integral part of its attempt to overhaul how medical devices are kept track of in the US. But not included in the final guidance is more than half of what the agency originally set out to define.
A Unique Device Identification (UDI) is, as its name implies, a system of identifying each medical device using a specific system.
The system has a number of advantages for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
At its core, the rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
The rule was originally mandated by the FDA Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).
In September 2013, FDA released a final version of the UDI rule which called for, among other things, a standardized alpha-numeric system of identifying elements to be contained within an FDA-run database known as the GUDID. As explained in an accompanying draft guidance, the GUDID is set to act as a repository for information such as the package identifier, quantity per package, package type, discontinue date and package status (discontinued, recalled, available).
Industry's reaction to the guidance was mixed. Some, such as industry trade group AdvaMed, took issue with how difficult it could be to make changes to product labeling under the GUDID system. "AdvaMed recommends that data elements should, as a rule, be editable to allow labelers to maintain accurate alignment between the GUDID and the product label," it wrote. "These points should be clarified in the next version of this guidance."
Another group, standards organization GS1, said the guidance should clarify how the database will treat a changeover from one barcode-issuing agency (such as GS1) to another. "This is important because certain key attributes impacted by such a change (e.g., Primary PI Number and Secondary PI Number) cannot be edited or changed in Published DI records after the grace period," it wrote.
Companies such as Johnson & Johnson raised other issues, such as how the system would accommodate products which are manufactured by different companies, or cases when one product is labeled by two separate companies. "We understand the Agency's desire for a 1 to 1 relationship, but this requirement implies that the products manufactured under these scenarios would require a separate UDI (DI) and this would significantly impact our current processes," it wrote.
Read all GUDID Comments here.
Now FDA is out with its final guidance on the GUDID, reflecting an extremely unusual approach.
While most final guidance documents make changes to the original draft, FDA said many of the changes that it plans to make to the document will instead come in future revisions.
"We plan to finalize this section separately," FDA writes a total of 14 times in the latest guidance document.
Why the change?
"In order to provide labelers access to the latest information as soon as it is available, and address sections that received the most comments and questions, sections of this document are finalized; sections still in draft state are noted and will be finalized at a later time," FDA explained. "A future document" will address those now-empty sections, FDA confirmed in its Federal Register posting on the guidance.
Still, changes were made to the final guidance, FDA noted. The changes were made to part of the draft guidance that "Received the most comments and questions," FDA said. For example, the final guidance contains considerably more detail about GUDID accounts and how they are used, shared and distributed. A section on Global Medical Device Nomenclature (GMDN)—basically a note indicating what kind of device the product is—has also been greatly expanded
The final guidance also removes about half of the existing content from the draft guidance, presumably to work on perfecting those details separately for a future draft guidance.
Final GUDID Guidance
Federal Register Notice