RE: What is Deep Brain Stimulation (DBS) and How does it Work?

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RE: What is Deep Brain Stimulation (DBS) and How does it Work?

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gentleshaid (70)in #science • 7 years ago

In 1997, the Food and Drug Administration (FDA) approved Deep brain Stimulation (DBS) essentially for cases and treatment of tremor. In April of 2003, DBS was also approved by the FDA as a treatment for dystonia.

Why FDA? just wondering. Its like NAFDAC approving a surgical procedure in Nigeria.

7 years ago in #science by gentleshaid (70)

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rickie (64) 7 years ago (edited)

Lolz....Yea, i see your point and analogy @gentleshaid.
But the DBS "brain pacemaker" chip or implant itself is classed as a "medical device", and so, under the United States's Medical regulations....

The FDA was developed in 1906 with the passage of the Federal Food and Drugs Act. It is a government agency designed to protect the U.S. consumers from unsafe or inappropriate use of food, drug, cosmetics, and "medical products".
Before "a device" or product gets FDA approval, well designed scientific studies have to be presented and investigated by the FDA. This is a long, arduous process intended to weed out less than proven products. Once a product gets FDA approval, the manufacturers are then allowed to advertise their product to the consumer according to what has been proven effective.

So, i guess that's why the approval of the FDA factored into the DBS procedure. Thanks for visiting @gentleshaid, I appreciate.

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