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How should you use animal studies in preparation for a regulatory submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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