As previously discussed, the preliminary approval is issued
with a set of conditions outlining the requirements and necessary
steps the Submitter should satisfy in order to achieve final approval.
Following the risk assessment, if done for the preliminary design
and subsequent final design phase, the Submitter's Final design phase
and the risk assessment of the preliminary design, the level of understanding
of the alternative and/or equivalency has increased. The preliminary
approval conditions may be revised as a result. That is, the requirements
to be met in order to achieve final approval will be described in
more detail. In addition, as the Submitter is in the process of selecting
testing and analysis methods, the Administration will have an opportunity
to guide and potentially specify explicit requirements for this selection.