About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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:

  • the rationale for the model selected,
  • the similarity of the selected model compared to humans,
  • the general animal study methodology you used,
  • whether there were standard operating procedures in place and followed during the study, and
  • how the quality assurance unit is independent and impartial with respect to the inspection of the data and the reporting of the results.

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:

  • the study groups,
  • the number of animals in each group,
  • identification of animals corresponding to study group allocation,
  • study duration,
  • the device design iteration used, and
  • a summary of study outcomes.

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