As we have learned and many have already mentioned, verification tests come about from the design specifications in the DSD. Each specification can have a test linked to it and will be explored during verification. However, not all specifications have to undergo design verification. Based on my experience, in the earlier stages, the quality representative/team will approve which inputs are “Critical to Quality” (CTQ). These inputs and specs are explored in the follow verification tests. The FDA does not choose these tests or suggest them. The design team develops the tests and the appropriate heads (like the Quality Engineers) will approve or give suggestions.