The qualified context of use for a DDT defines the boundaries within which the data, available at the time of initial qualification, adequately justify the use of the DDT. We encourage DDT submitters to be judicious in scope with regard to the context of use proposed in their initial submission. As data from additional studies are obtained over time, submitters of DDTs will be able to continue working within the DDT Qualification Programs to submit additional data and expand the qualified context of use.
