New Draft Guidance Issued by FDA for Animal Studies for Medical Devices

Published Date : Oct 16, 2015

The United States Food and Drug Administration has issued a new draft guidance that highlights suggested industry procedures and practices while reporting as well as conducting animal studies for medical devices. The most recent guidance will be kept open for the public to comment upon over the next 90 days. It was released following a paper by the University of Edinburgh, which indicated that researchers are not doing their due diligence to eliminate potential bias from animal testing. This, they said, could possibly be compromising on the authenticity of their findings. 

During the first phase of device or drug development, researchers test the given product on animal systems in order to analyze the possible safety concerns. This could also be done to ascertain or show proof of concept in a living system. Biased or flawed animal testing, even if unintentional, misrepresents the findings of the research. This could result in failed clinical trials conducted with human subjects and even massive losses of time and money. 

Led by Malcom Macleod, a team of researchers from the University of Edinburgh surveyed thousands of animal studies that had been peer reviewed and discovered that a major section of authors were not doing enough to make certain good research practices were being followed. The findings were published in PLOS Biology and suggested that two thirds of the animal studies being conducted in the United Kingdom had a rather questionable authenticity owing to poor research design. 

Speaking to The Guardian, Macleod said that researchers could definitely do a lot more to ensure good research practice. If researchers do their due diligence, science will become stronger in terms of findings being translatable into new disease treatments.

Some of the major concerns Macleod had were that studies blindly evaluated animal health at the time of conclusion of the treatments, failed to randomize animals into treatment and control groups, or did not keep a record of animals that were eliminated from the studies.