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What should you consider for study equipment in an animal study?
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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.

Given that a medical device animal study is typically sophisticated in its components, and in recognition of the shift from the use of sponsor-owned to contract study facilities, FDA recommends that study sponsors, their consultants, and the study director carefully assess the care, maintenance, and knowledge about the contract equipment used in the study. FDA encourages early and frequent interaction between personnel involved in the planning of the animal study and those who will actually perform the study. FDA believes this dialogue is especially important to ensure that the study facilities have the proper ancillary equipment, supplies, and resources for the study. For example, imaging equipment and personnel may need to be as advanced as those found in human interventional suites or operating rooms to properly emulate the clinical situation.

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