On October 14, 2015, the United States Food and Drug Administration released a document providing draft guidance for animal studies used in medical device development and testing.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.
The recent draft guidance document, entitled General Considerations for Animal Studies for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff, is not yet final. If the FDA chooses to issue the document, however, it will supersede the current draft guidance on the subject, which was published in July 2010.
In the proposed document, the FDA increases the scope of the guidance and proposes a number of strong recommendations to industry professionals producing medical devices. For example, the document strongly recommends that industry members work closely with pathology experts like veterinarians certified by the American College of Veterinary Pathology when developing the study protocols. The FDA also makes a strong recommendation that parties submitting studies “conduct definitive animal studies on the market ready device except as required to scale, if needed, to implant in the animal model.”
The second major change and strong recommendation in the draft guidance emphasizes the importance of using the final clinical design, market ready device, or final design for the studies. In fact, the FDA repeated these terms several times throughout the document, suggesting the importance of this theme to the agency’s overall shift in guidance for animal studies involving medical devices.
While these recommendations are not entirely new, compared to the existing guidance document, the agency has raised the strength of its recommendations and included additional references to how studies should be conducted going forward.
Of course, one of the most obvious differences between the existing guidance and the draft guidance is that the FDA intends to widen the scope of instances in which the guidance is applicable, which is currently limited to devices used in treating cardiovascular conditions. The new guidance would encompass all “medical devices intended for use in humans, as defined in section 201(h) of the Federal Food, Drug and Cosmetics Act.”
If the draft guidance is finalized, the instances in which parties use reports involving animal studies on medical devices will likely increase, bringing even more scrutiny to the legitimacy of these reports and scrutiny over whether the individuals conducting the study met the specific requirements and duties associated with studying medical devices’ impact on animal subjects.
If you or someone you love has been injured due to a dangerous or defective medical device, you may be entitled to compensation. The experienced and dedicated lawyers at Moll Law Group have provided compassionate and aggressive legal counsel to victims throughout the nation, including in New York, California, and Texas. Call us now at 312-462-1700 or contact us online to set up your free consultation.