The FDA is clarifying language related to the direct marking of medical devices for unique device identification purposes, including the definition of reprocessing.
In draft guidance released June 26, the agency explains what form a direct marking should take. Under the UDI final rule released in September 2013, a UDI must be permanently affixed to reusable medical devices that require reprocessing between patients. The requirement applies to all device classes, except low-risk Class I devices that bear a universal product code on their labels and packages.
The direct marking requirement came about because medical devices can be used for months or years and may become separated from their original labels and packages that also bear a UDI. Questions arose about what requirements the direct marking must meet.
To that end, the draft guidance “helps people understand that direct marking can be fulfilled a number different ways, such as a permanent label or tag,” Jay Crowley, vice president and UDI practice lead at USDM Life Sciences and architect of the final rule, tells IDDM.
The FDA decided not to specify any particular approach to direct marking because of the wide variety of existing devices, use conditions, and reprocessing methods for these devices,” the guidance says.
Indeed, labelers may use methods such as etching, attaching a permanent plaque to durable equipment or placing a radiofrequency identification or similar tag on the device.
Another facet of direct marking the document addresses relates to the definition of reprocessing.
“There was ambiguity and confusion for the purposes of UDI,” says Crowley, who praised the FDA for adding clarifying language in the definition.
“For purposes of UDI direct marking requirements, we consider a device that is intended to be cleaned and either sterilized or disinfected before each use to be intended to be reprocessed,” the guidance states.
Devices that are only meant to be cleaned between uses by different patients would not fit the reprocessing definition for the purposes of UDI direct marking.
In addition to these clarifications, the draft guidance confirms the compliance dates for each device class.
It also explains that a labeler may file for an exemption if the direct marking would affect a device’s safety and effectiveness. If safety and effectiveness would be affected, but the manufacturer chooses to apply the marking, the FDA would generally require a new 510 (k) submission.
In the end, Crowley says the document should prove useful. “It’s a good document, and it should help people confused by some aspects of the UDI rule,” he says.
Industry trade group AdvaMed also expressed appreciation for the FDA issuing the guidance, adding that it is reviewing the document for specific comments.