FDA recommends that you consider the following general principles when developing animal study protocols for medical devices:
- Good Laboratory Practice (GLP) applies (21 CFR Part 58) for animal studies that are to be submitted to support the safety of a medical device. If your animal study was not conducted in compliance with Part 58, your statement provided in your submission explaining the reasons why the study was not in compliance with GLP regulations should describe in detail all deviations from the regulations. The statement should include information that will help FDA reconstruct the study, explain any confounding variables, and demonstrate that authentic and complete test data have been collected and reported.
- The animal model selected should be generally accepted for the study of the device type. There should be a reasonable amount of scientific evidence that the animal model has utility for the study of the device type. The FDA recognizes that the utility of animal testing may be limited in certain situations, and it may be most appropriate to proceed with limited clinical evaluation in humans, if scientifically justified. In other cases, an alternative animal model may be used and appropriately justified.
- FDA’s primary purpose in recommending an animal study is for the applicant to provide evidence of safety, including performance and handling. Note that in many cases, the performance of a particular device is intricately linked to its safety, such as for products that provide circulatory support.
- A secondary objective for conducting the animal study can be to evaluate the efficacy of the device or to demonstrate proof of principle.
- The in vivo setting generally provides an initial assessment of how the device interacts with biologic systems and also how the biologic system may affect the device, such as via device corrosion and structural deformities.
FDA is available to review your rationale for and design of an animal study as part of a Pre-Submission. Additionally, it is important to consider the following points when designing your study:
- adequacy of controls,
- timing and route of intervention, and
- methods to minimize bias (e.g. blinding, randomization, use of controls, sample size based on expected magnitude of the biological response, reporting missing data, and clearly stated statistical considerations).
If you are uncertain regarding elements of the animal study that are important to the FDA, please initiate contact with your respective review division for clarification.
You should observe the best practices of refinement, reduction, replacement, and current standards of humane veterinary care and use. This may also involve consideration of available validated alternatives.