“Safety means that, for a given medical device with a defined intended use (including intended patient population) and use specification, which is both verified and validated, reasonable assurance exists that possible risks associated with the device are adequately identified, disclosed, and acceptably controlled when weighed against the evaluated benefits. This includes the consideration that safety-critical clinical functions are adequately defined with adequate reliability and that the health benefits of using the device outweigh the risks.”
“The criterion for benefits outweighing risks implies that the device provides the benefits as claimed and reasonable assurance exists that the risks are adequately identified and assessed. If the device does not provide any benefits, then any risks introduced would be unacceptable".