Regulation
In the United States, CES technology is classified by the Food and Drug Administration as Class III medical devices and must be dispensed by or on the order of a licensed healthcare practitioners, i.e. a physician, psychiatrist or nurse practitioner; psychologists, physician assistants, and occupational therapists who have an appropriate electrotherapy license may prescribe CES, dependent upon state regulations.
As a result of the 1976 Medical Device Amendments, CES was placed in Class III by the FDA. Manufacturers who prove both safety and efficacy may enter the market, with FDA clearance, utilizing the 510(k) process instead of the premarket approval process, at this time.
Read more about this topic: Cranial Electrotherapy Stimulation
Famous quotes containing the word regulation:
“Nothing can be more real, or concern us more, than our own sentiments of pleasure and uneasiness; and if these be favourable to virtue and unfavourable to vice, no more can be requisite to the regulation of our conduct and behavior.”
—David Hume (1711–1776)
“Nothing changes my twenty-six years in the military. I continue to love it and everything it stands for and everything I was able to accomplish in it. To put up a wall against the military because of one regulation would be doing the same thing that the regulation does in terms of negating people.”
—Margarethe Cammermeyer (b. 1942)
“Lots of white people think black people are stupid. They are stupid themselves for thinking so, but regulation will not make them smarter.”
—Stephen Carter (b. 1954)