NEW YORK (GenomeWeb) – Canadian regulatory agency Health Canada last week issued finalized guidance for the labeling of in vitro diagnostic devices, setting requirements for label implementation, electronic labeling, symbols on small containers, and blood glucose monitoring systems.
The finalization comes just over 18 years after Health Canada released the first draft version of the guidelines.
According to Health Canada, IVD device labels must include all information required under Canada's Medical Devices Regulations — for example, the name of the device and the manufacturer, directions for use, and an expiration date — either on the device itself, on an outer or inner package, or in a package insert. Directions for use should also include appropriate warnings and precautionary statements.
Labeling information may be made available electronically, such as via internet download or on an electronic storage device, but only for devices not sold to the general public, the guidance states. "The information provided electronically should be easily navigable," it adds, and "manufacturers should ensure that the electronic label is identical in content to the paper format, where applicable."
In the case of containers too small for full labeling, device manufacturers may use internationally recognized symbols as long as a glossary of terms associated with the symbols is provided.
Health Canada's guidance also includes special considerations for blood glucose monitoring systems including blood glucose meters, lancing devices, controls, and test strips. Labels for these devices must also note if alternative sites may be used; if a meter is to be used for one or multiple individuals; that the device is not intended to diagnose diabetes; and whether it is intended for neonatal testing or not. Glucose monitoring system labels must also indicate whether the system is to be used for self testing or for professional use on a single patient.