- The Food and Drug Administration issued draft guidance clarifying the form and content of special tracking labels for medical devices.
- Specifically, unique device identifiers must appear in both plain text and a scannable automated identification and data capture (AIDC) version that could be included in a patient’s EMR.
- The guidance comes as manufacturers and labelers of Class II devices, such as contact lenses and ultrasound scanners, are gearing up to comply with the package labeling requirements this fall.
Under the 2013 UDI rule, devices must include both a device identifier and a production identifier to ensure proper tracking throughout their lifecycle. The UDI identifies the specific model and key information about its production, such as date of manufacture and serial number.
If space on the device or package is too small for the AIDC version of the UDI, it may be split into sections, the FDA says. For example, the DI and PI could be presented in separate linear bar codes. These should be located adjacent to each other, with the DI appearing first.
The guidance also clarifies that a labeler may use more than one type of automated form — e.g., a linear bar code and 2D data matrix code — to aid users with different types of UDI capture technology.
Both versions of the UDI should include a data delimiter, defined as a “character or set of characters that identifies specific data elements within an encoded data string.” According to the guidance, “the data delimiters allow users to parse the DI and PIs from the easily-readable plain text UDI, as well as to verify that the information encoded in the AIDC form of the UDI matches the easily-readable plain text form of the UDI.”
FDA began requiring UDIs on Class III devices in the fall of 2014. Starting Sept. 24, UDIs must appear on Class II devices and standalone software. Labelers of Class I devices have until Sept. 24, 2020, to comply with the rule.
But while Class II devicemakers are mostly prepared to report their UDIs, there are still some big issues around implementation, including what qualifies as a regulated medical device, Jay Crowley, vice president of UDI Services and solutions at USDM Life Sciences in Santa Barbara, CA, and chief architect of the FDA’s UDI systems, told Healthcare Dive earlier this year.
Interested parties have 60 days to comment on the draft guidance.