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What are some factors to consider in the evaluation of how a device affects an animal?
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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.

To best characterize the device effects on the animal, FDA recommends that the process be active and specific, rather than passive and general. Important attributes to consider for evaluation include, but are not limited to:

  • respiratory rate, pattern, and depth
  • blood pressure
  • heart sounds and pulse character
  • mucus membrane color at rest and under exertion
  • attitude
  • mentation
  • gait
  • presence or absence of abdominal, bladder, or bowel distension

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