According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood
glucose self-testing kit?

Who has the PRIMARY responsibility for recall of products with quality defects?

Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?

A superiority advertising claim for a product versus its competitor's product can only be made under which
of the following circumstances?

A regulation change is imminent and may require further non-clinical testing on a product currently in
Phase III clinical trials. What is the most appropriate action to take FIRST?