The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
These trials are very expensive in outlay, personnel time and elapsed time. FDA regulations are designed to ensure that trials conducted in the US are performed with a number of safeguards, not only for the patient undergoing the trial, but for the sponsor of the trial, to ensure that sufficient thought has been given to protocol development, patient safety, definition of endpoints, data analysis, and data integrity.