Guiding Principles for Technical Review of Medical Device Animal Experimental Research Part 2: Experimental Design and Implementation Quality Assurance (Draft for Solicitation of Comments)
The main purpose of animal experiments on medical devices is to study the safety and effectiveness of medical devices. Generally, the subject of animal experiments in medical research may be a new diagnosis and treatment method and principle.
Establishing a well-compliant animal experimental model in the research process is the key to the success of the experiment. Of course, there are often situations where it is impossible to establish an appropriate animal experimental model. Whether to establish a highly compliant model in medical device animal experiments depends on objective conditions and the purpose of the research.
When the animal experiment model is established appropriately, the effectiveness research can be used as an important content in the animal experiment of medical devices, that is, the actual use of the test device and the conformity of the intended use. However, such research results cannot be used as the effectiveness evaluation of the medical device. It can only be used as an auxiliary reference for whether it can be transferred to the human body for clinical research, and it can also be an input and output information for the study of the mechanism of diagnosis and treatment.