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.
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
heart sounds and pulse character
mucus membrane color at rest and under exertion
presence or absence of abdominal, bladder, or bowel distension