Insulin product and pump compatibility claims: Regulatory notice
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Insulin pump manufacturers are reminded of the regulatory requirements for making claims in the insulin infusion pump labelling or marketing materials for compatibility with an insulin product.
For an insulin pump to be marketed in Canada as compatible for use with an insulin product:
- the product monograph of the insulin product must indicate that it's authorized for use in insulin pumps
- the labelling of the insulin infusion pump must state the specific insulin products that the pump is compatible with
Marketing of insulin infusion pumps is regulated under the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR). Insulin infusion pumps undergo pre-market review by Health Canada's Medical Devices Directorate (MDD).
For an insulin infusion pump to be marketed for use with a specific insulin product:
- the specific insulin product must be authorized by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) for general use by continuous subcutaneous insulin infusion (CSII)
- you must submit a device licence application (new or significant change amendment) to MDD demonstrating that
- the pump and insulin product are compatible
- the pump's labelling clearly lists the compatible insulin products
Insulin products, including biosimilar insulins, are regulated under the FDA and the Food and Drug Regulations. These products undergo pre-market review by Health Canada's BRDD before authorization.
An insulin product must be authorized for general use in CSII in infusion pumps. This authorization for CSII in the product monograph of the insulin product is preliminary in nature. It does not authorize marketing of that insulin product with any specific model of insulin infusion pump in Canada.
To demonstrate compatibility between an insulin pump and the insulin product, a medical device application should include evidence to address the following safety and effectiveness considerations:
- patient harm due to incompatibility between the insulin product and the pump (including the pump's compatible infusion sets and cannulae) caused by:
- over-or under-infusion of the insulin product, including blockage (occlusion)
- adverse impacts on the quality of the insulin product, including degradants and impurities
- exposure to harmful substances leached from pump materials into the infused insulin product
- insulin product damaging pump materials or compromising pump function
- any conditions that may affect insulin product stability (for example, temperature, light exposure, agitation, duration of automated insulin delivery shut-off)
The claim of compatibility between the insulin pump and a specific insulin product is considered part of the indications for use of the insulin pump. Health Canada considers the addition of a new insulin product to the list of compatible insulin products, for an existing licensed insulin pump, a significant change. This also includes adding compatibility claims for an insulin biosimilar for which the associated originator insulin is already included in the pump's list of compatible insulin products.
To make such a change, you must amend your licence (defined in sections 1 and 34(a) of the MDR).
Note: the list of compatible insulin products is considered a part of the indications for use, regardless of where it appears in the device labelling.
If you have questions or would like to discuss your application with us, you may contact us as follows:
Medical Devices Directorate (MDD)
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
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