The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998.
The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act, which requires product labels to be written in both French and English.
Additionally, the guidance has been rewritten for clarity and conformance to the agency's current good guidance practices.
The requirements for labeling IVD devices are set out in Canada's Medical Devices Regulations.
In general, all IVDs must be labeled in accordance with the regulations, either by including the label on the device itself, on the outer or immediate container or within the included materials such as the package insert, brochure or user manual.
The label itself must state a diagnostic's name, manufacturer name and address, intended use, unique identifier and other specific elements, such as expiry date and storage conditions, depending on the characteristics of the diagnostic.
According to Health Canada, electronic labeling may be used to present the information required for directors for use for certain diagnostics not sold to the general public. However, the agency stresses that the electronic labeling must be identical to the physical version of the label.
"This information may be provided as downloadable from the internet and/or on electronic data storage devices (e.g., compact disc, digital video disc, or USB flash drive). The electronic label or internet web address must accompany the device at the time of sale and/or delivery and be displayed in a manner that alerts the user to its purpose," the agency writes.
For diagnostics with limited space on the container to display a label, Health Canada says manufacturers can rely on "internationally recognized symbols" to convey information, as long as the package insert or directions for use contain a glossary that provides a full explanation for the symbols.
Blood Glucose Monitors
The final guidance also contains a new section providing additional considerations for labeling blood glucose monitoring systems, including the glucose meter, lancing device, controls and test strips.
The new section directs users to a 2014 guidance, New Requirements for Medical Device License Applications for Lancing Devices and Blood Glucose Monitoring Systems, and specifies information that must be included in the intended use section of the label:
- If applicable, alternate sites that may be used.
- If the meter is to be used for multiple users or a single user.
- Not for the diagnosis of diabetes.
- If it is intended for testing neonate samples or not.
- If the meter is to be used for self-testing and for professional use on a single patient, the intended use must indicate this.
For systems intended for multiple patients, Health Canada says the label should contain instructions to "clean and disinfect the meter between patients, to change gloves between patients and to only use auto-disabling single use lancing devices."
Labelling of In Vitro Diagnostic Devices