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FDA Approval Process

We all know the role of the FDA for the granting of permission for regulated products.

As can be seen on television, there many electrical stimulation devices available for skin conditioning.  What must be determined is whether or not they are regulated by the FDA.  It is possible that the EBS may be created in several modalities.  One Medical, and one Nonmedical.

In our pursuit of a medical solution, there is no doubt that the process of FDA approval must begin immediately.

Astounding FDA Document: 

"FDA has approved seven electrical bone growth stimulators...."

Scoll down to "Healing Helpers"

Division of General, Restorative, and Neurological Devices

Wireless Medical Telemetry : http://www.fda.gov/cdrh/emc/wmt2.html

FAD Computer and Software Related Documents:  http://www.fda.gov/cdrh/compsoftware.html

FDA Advisory Committee: http://www.fda.gov/oc/advisory/default.htm

FDA Advisory Committees in the
Center for Devices and Radiological Health

Discussion Regarding Electrical Stimulation Devices at the FDA:

OFFICE OF SCIENCE AND TECHNOLOGY

Annual Report

F i s c a l Y e a r 1 9 9 9

O c t o b e r 1 , 1 9 9 8 – S e p t e m b e r 3 0 , 1 9 9 9

After opening the PDF file, search for "Electrostimulator"

 

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Last modified: 05/07/13