Hello James,
I could not speak directly to why or reason Section 7.1.3 is listed as excepted for Health Canada, but in my experience sometimes accelerated studies are accepted depending on the assay and known information related to the components. I have found this really does depend on the assay because some contain biological components (antibodies, antigens) which are more volatile. Regarding design changes this also depends on the type of change, the current expiration date/shelf life, and the assay. If the change impacts stability, there might be a reason to start the real time testing, wait for the first test point, and then submit the design changes, but again depends on a few factors. Because definitely conducting a design change can not wait 2 or 3 years for the real time data, so accelerated is an option - there should be the justification and reason for doing this - not just because you can.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Dec-2022 11:45
From: James Baker
Subject: Health Canada position on accelerated stability for establishing shelf life claims on IVDs
Hi All,
I'm hoping someone on here maybe able to provide some clarification on this subject with regard to both new IVDs and those that undergo a design change? I note from Health Canada's list of recognised standards that CLSI EP25 is listed, but section 7.1.3 is excepted.
Am I correct in my interpretation here that accelerated studies for either new IVD devices or those that have undergone a design change are not permissible to establish stability claims for devices that are/to be licensed in Canada?
I am currently working on a project which will introduced a design change to a Class II IVD currently licensed in Canada and will impact stability, hence my question.
Thanks in advance.
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James Baker
Regulatory Affairs Specialist
United Kingdom
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