FDA –  Food and Drug Administration:
(1)    Created in the Act of 1938, which regulated drugs.
(2)    Medical Device Amendment in 1976 that included devices.
(3)    Each state has its own FDA, but the federal law preempts state law in most cases.
(4)    FDA has the role of setting guidelines whereby manufacturers obtain approval for marketing their product, and gain approval for the labeling of such product.
(5)    They are NOT practice guidelines, and do not tell the doctor how to practice, nor do they tell the medical community how to use the device/drug.
(6)    There are sometimes situations where the drug or device is not used like the label says to use it.
(a)    EX: Valium – drug is widely used for epilepsy even though its primary purpose is for anxiety.
(b)    EX: Pedicle Screws – used not only in the neck for vertebrae but also to fuse other bones in the body.