(f) animal studies that provide direct evidence of safety and performance of the device, especially when no clinical investigation of the device was conducted; (g) clinical evidence. (D) Detailed information will describe test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions. Where no new testing has been undertaken, the dossier should incorporate a rationale for that decision, e.g. bio-compatibility testing on the identical materials was conducted when these were incorporated in a previous, legally marketed version of the device. The rationale may be incorporated into the Essential Principle checklist