FDA Proposes New Guidance on Medical Device Animal Studies
On October 14, 2015, the United States Food and Drug Administration released a document providing draft guidance for animal studies used in medical device development and testing. In many lawsuits regarding defective medical devices, studies and guidance documents of this nature are used by the parties’ experts to testify about certain aspects of a party’s legal theory or to rebut testimony from another expert.
These studies will frequently provide evidence regarding the purported safety of a drug or device based on how the drug or device affected animals used in studies. As a result of this precarious situation, there are strict regulatory and industry standards associated with how these studies can be performed.