Preclinical testing Summary of preclinical testing that has been performed on the investigational medical device, together with an evaluation of results of such testing justifying its use in human subjects. The summary shall include or, where applicable, refer to the results of: (a) design input and design output documents, (b) in vitro tests, (c) mechanical and electrical tests, (d) reliability tests, (e) validation of software relating to the function of the device, (f) any performance tests, (g) ex vivo tests, and (h) biological safety evaluation.