Devices

Concerns Raised About UDI Draft Guidance

AdvaMed says it appreciates FDA’s interest in providing guidance and further clarity regarding the form and content of a device’s unique device identifier (UDI). In comments on the agency’s draft guidance on the form and content of a UDI, the association says it does not agree that data delimiters are a component of a device’s UDI that must be included in the easily readable plain-text form. It also recommends that the agency allow manufacturers to use symbols in place of or in combination with data delimiters for the easily readable plain-text version of the UDI. “Symbols associated with the specific string of information related to UDI capture technology ensure unambiguous interpretation of the information encoded within the UDI system,” it says. “We also believe that using symbols will make it much easier for individuals who do not have knowledge of data issuing agency coding systems to understand the labeling.”

Becton Dickinson says the UDI system “represents a significant step forward in the management and oversight of the U.S. healthcare system…. While we agree with most of the points in the draft guidance document, BD believes that a few of the points should be modified to ensure continued adoption of UDI.” It says that one of the points in the draft may have the unintended consequence of disrupting existing supply chain practices unless further refinements are made to FDA’s guidance or to the Issuing Agencies General Specifications. “Unless this point in the draft guidance is modified,” the company says, “labelers that have selected GSI as their issuing agency will be unable to follow their Issuing Agencies Specifications. Furthermore, there may be disruptions to existing automated scanning systems.”

Johnson & Johnson asks FDA to reconsider the need for this specific guidance. “We believe this draft guidance should not be finalized because it specifies requirements that exceed the Unique Device Identification System final rule and it is not consistent with the requirements outlined by the Issuing Agencies, ISO/IEC standards, or previously published FDA guidance and recommendations,” it says. “Finalizing this document would result in costly relabeling of currently UDI-compliant product with no improvement in patient safety.” The company says it generally agrees with AdvaMed’s comments and is particularly concerned with the overall prescriptive nature of the guidance.

Cook Group provided specific line-by-line comments.

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