FDA has created three classes of devices:
(1)    Class I: A simple device with absolutely no threat to patient health.
(a)    A percussion hammer, a syringe.
(b)    FDA only requires that the Company show to the FDA that it is produced according to good manufacturing principles.
(2)    Class II: Have to show proof of efficacy.  Instead of general controls, there must be specific controls.
(a)    EKG
(b)    FDA wants to know how accurately does the machine portray the date that it is relfecting.
(c)    FDA wants to make sure the machine will be safe and will not harm the patient.
(d)    Usually not a device put into the body, unless implanted in the body to merely sit there without a function.
(3)    Class III: Analogous to the drug process.  There has to be a pre-market approval process with a study, an IRB, etc. (like the drug process).
(a)    The company has to get an investigational device exemption, which allows them to give the device to clinics to do the study.
(b)    FDA approves the marketing of the device and the labeling of device, but do not tell the doctor how to use it.  They don’t allow the company to put on the label that the device can be used for something other than what the FDA approves the device for.