Hi All,

I believe that all of you have touched upon very valuable points. I would like to emphasize that pre-clinical trials (animal trials) are not a safety indicator for many devices. For example, Inhalation devices are not usually tested on animals due to the different anatomical properties between humans and animals. In the case of death being one of the potential harms of the clinical study, the manufacturer and/or study sponsor should ensure that all risk management processes have been implemented in order to reduce such risk to the lowest possible case. If that risk cannot be eliminated or reduced, the manufacturer can do a risk/benefit analysis to determine if the benefits of the product outweighs the risk of death.