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07:59
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Originally posted by JustIntonation:
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This is all about their Quality Management System being appropriately defined. What the TGA will want is some sort of documented internal procedure that sees a regular review of the WHO Variant of Concern list along with a specified process to retest the carts and reader against significant new variants. Partly this is because the TGA are concerned with actual or implied statements about efficacy - we are making a number of pretty strong claim for our product so we need to be able to show them that we are committed long term to keeping up with what happens.
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One would think that this type of statements around processes for on going monitoring and testing for future variants would have / should have been in their original proposals.
