Various tests need to determine the safety of the product before use in clinical studies (21 CFR 312.23(a)(8)). A complete description of material composition should be made available, detailed specification for formulation and chemical composition. The preclinical data is usually derived from animal studies. The test chosen should be geared towards the safety raised by your product. The FDA encourages one to design testing strategies that incorporate both testing of cellular product and delivery system in a single study. The animal studies should include biological response to the device/product, durability response, toxicology, bacterial endotoxin, pyrogen testing, study duration, sterilization and packaging. Tests may vary depending on its application. For neural biomaterial electrode stimulation tests may be required, for orthopedic mechanical testing and for urinary liquid flow testing may be required.