Posted 18 April 2016 | By Michael Mezher 

UDI Compliance: What's Coming From FDA in 2016

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Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told the UDI Conference in Baltimore on Monday.

Under the UDI rule, FDA established a phased, risk-based, approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class III devices in 2014; implantable, life-supporting and life-sustaining devices in 2015. Class II devices will need to comply later this year and Class I and non-classified devices will need to have UDIs in 2018.

Device manufacturers are expected to submit their device identifiers (DI) FDA's safety database, known as GUDID (Global Unique Device Identifier Database), by the applicable compliance dates.

GUDID Enhancements

According to Indira Konduri, GUDID program manager at FDA, "[FDA's] plan for the remainder of the year is to focus on infrastructure improvements to make sure [GUDID] can handle the anticipated volume of Class II [devices]," referring to the 24 September 2016 compliance deadline for those devices.

Konduri also discussed a new data element in GUDID, called a device identifier (DI) trigger. These triggers are data elements within a device's GUDID entry that, if changed, would require a device to obtain a new DI.

These elements "really change what the device is about," Konduri said. "If you say a device is for single use … it's one type of device. If you change your mind and say 'I'm going to change this and now make it a multi-use device' you really need to assign a different DI," she said.

In general, "these new DI trigger elements cannot be edited after an entry is published in GUDID," Konduri said. However, FDA is giving companies a 30-day grace period to edit all GUDID data elements (except for publishing date) without needing to generate a new DI.

Over the past year, Konduri said the agency has made a number of enhancements to GUDID, including:

• The ability to accept de novo premarket submissions
• The ability to submit package DIs for devices with a single device in a package
• The ability to export all submitted DI records as XML files, rather than being limited to 100 at a time
• Refinements to what data different user types can access

Additionally, Konduri said that within the next month or so, FDA will introduce a new data element called "previous DI" to allow companies to link to DIs for devices acquired through mergers and acquisitions. Down the road, Konduri said

that FDA plans to add a data element for a company's previous name too.

Working out the Kinks

Despite FDA's efforts to develop guidance for UDI and GUDID, the agency is still identifying areas where more details are needed.

According to Erin Quencer, regulatory analyst at FDA, the agency hopes to provide some of these details when it finalizes its guidance for UDIs placed directly on devices, which is expected by the end of 2016.

Cosigned/Loaned Devices

Quencer also said that FDA is working to develop a formal policy for UDI compliance for devices that are consigned or loaned to healthcare providers. FDA has proposed a three year exception from UDI requirements for devices manufactured prior to their UDI compliance date.

However, Quencer said: "Industry has expressed some concern … about devices that are consigned or loaned to hospitals or other healthcare facilities. Their concern is that [FDA] would require these … devices to be removed [from use] in order to add the UDI to the label. Some of these devices have life expectancies beyond this three-year exception. We want to assure [manufacturers] that we do not believe the goals of the UDI program would be served by requiring these devices … to be removed," from their use settings in order to meet UDI labeling requirements.

Another issue FDA has identified is how to it will handle a data element in GUDID that FDA refers to as "unit of use DI."

"The purpose of [unit of use] is to allow linking of a single device at the point of use directly to a patient," in situations where a device package contains multiple units of a product. "This has been a very challenging concept for us internally," Konduri said

Konduri said that the agency is currently weighing how to move forward with unit of use, adding: "This may be a concept ahead of its time … We want to make sure it's a value added data element."