For me-too medical devices, on what basis should manufacturers choose biological tests to conduct?
Manufacturers producing a me-too medical device intended for implantation in the human body, conducting a full biocompatibility study including implantation effect that takes more than one year does not seem logical. With the availability of a reference medical device of the same material & intended use, how can the manufacturer choose the required biological tests?
Analytical toxicology
Clinical and translational toxicology
Medical devices
Molecular and biochemical toxicology
Regulatory and Safety Evaluation
Charles Az