When preparing regulatory submissions, including IDE, 510(k), HDE, and PMA submissions and de novo requests, FDA recommends that you include all relevant information collected as part of your animal studies. The summary of nonclinical studies in your submission should discuss the number of animal studies conducted, and include the following information for each of the studies:
In addition, you should include your rationale for your transition from pilot, validation, or proof of concept animal studies to pivotal animal studies, or from one pivotal study to the next, as this information assists us in understanding how you comprehensively assessed device safety, and performance and handling across multiple studies. You should also describe any design changes to the device that were implemented after completion of all animal studies.
FDA recommends that you also provide a tabular representation of key parameters for each study, including the following information: