I don’t think FDA clearance is required for this........
I disagree.
What was their process for sterilization before implantation?
What effect does that fuel cell have on blood?
Any product that comes in contact with body tissues could cause an allergic reaction. What kind of biocompatibility studies have been done?
What happens if the device is placed in an MRI?
What happens if it is X-rayed?
What happens if it is exposed to radiation treatments?
Diathermy?
Electric blankets?
Ipods?
What kind of scarring is left if the device is removed?
I could go all day.