Many of the medical device industry's biggest names have begun to weigh in on a new proposal from the US Food and Drug Administration (FDA) to launch a database intended to facilitate the operation of its Unique Device Identification (UDI) rule, offering a wide range of proposed changes.

Background

A UDI is, as its name implies, a system of identifying each medical device using a specific system.

The system has a number of allures 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 July 2013, FDA released a draft version of the rule which called for, among other things, a standardized alpha-numeric system of identifying elements to be contained within an FDA-run database. The FDA Safety and Innovation Act (FDASIA)of 2012 later set a statutory date by which the rule was supposed to have been released -31 July 2013-but the date came and went with no release of the rule by OMB.

On 20 September 2013, FDA finally issued the rule, and with it an extensive draft guidance on the Global UDI Database (GUDID) to be used as a repository of all device-not production-identifier information.

The database will thus hold information such as the package identifier, quantity per package, package type, discontinue date, and package status (discontinued, recalled, available).

GUDID Guidance

But in comments submitted in recent weeks to FDA, dozens of companies and other stakeholders have taken issues with parts of the guidance, offering the agency suggestions on how to improve what will undoubtedly be an integral part of the UDI implementation process.

GS1, an international standards organization which has applied to be an issuing agency for FDA's UDIs, said the current guidance isn't clear about how the "device count" should read for kits. At present, FDA treats a kit as a single device, but GS1 said it might be useful to indicate how many parts should be in each kit in the GUDID. The same would be useful for combination products, it wrote.

GS1 also said the guidance could benefit from more clarification regarding when a labeler changes from one barcode issuing agency 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.

A similar point was made by trade group AdvaMed, which said the guidance was troublesome in that manufacturers have a difficult time making changes to product labeling.

"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."

Manufacturers' Perspective

Johnson & Johnson meanwhile highlighted problems with the DUNS aspects of the GUDID system. The guidance calls for each labeler name and address in the database to match the address on the medical device. In other words, one DUNS number, one labeler.

However, J&J wrote, "There are many instances where the same product is manufactured under two different legal manufacturers (labelers) and manufacturing sites or where product is manufactured at one site and is labeled at two different labelers. 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."

Boston Scientific, another device manufacturer, said the guidance had a number of inconsistencies relative to the UDI rule itself. Specifically, under 21 CFR 830, certain information is required to be sent to FDA for inclusion in the GUDID. Other information, as outlined in 21 CFR 830.340, is voluntary, and is subject to a different submission process.

"BSC strongly recommends modifications be made to the GUDID Guidance and the GUDID to ensure requirements are consistent with 21 CFR 830," it wrote.

In all, FDA received 21 sets of comments from companies including Abbott, GE Healthcare, Covidien, Merck, Cook Group, the Orthopedic Surgical Manufacturers Association (OSMA), the American Hospital Association and the standards group ICCBBA.

GUDID Comments to FDA