About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
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.

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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