Frequently Asked Questions

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

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Clinical: MedTech

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