| A small battery-operated device delivers | | | | FDA Position |
| low-intensity electricity to points around the eyes. | | | | In respect to the legal status of MCS Therapy, |
| This stimulation is thought to increase the blood | | | | the Food and Drug Administration regulates the |
| flow to the eyes and as a result the eye is better | | | | sale of medical devices. Before a medical device |
| nourished, more oxygen gets to the tissues, and | | | | can be legally sold or used in the U.S., the person |
| waste products are more efficiently removed. | | | | or company that wants to sell or use the device |
| It is also believed that MCS helps to stimulate | | | | must seek approval from the FDA. |
| retinal cells that have become somewhat dormant | | | | To gain approval, they must present evidence |
| and sluggish. | | | | that the device is reasonably safe and effective |
| Is Microcurrent Stimulation Safe? | | | | for a particular use. The devices used in MCS |
| The procedure is safe, noninvasive and painless. | | | | therapy were originally developed and approved |
| No side effects or adverse reactions have been | | | | for the relief of chronic, untreatable pain. |
| observed. | | | | Once the FDA has approved a medical device, a |
| No increase in the conversion to the wet form of | | | | doctor may decide to use that device for other |
| age related macular degeneration has been seen | | | | indications if the doctor feels it is in the best |
| in those who have been treated. | | | | interest of a patient. |
| In a consensus statement by the NIH reports | | | | Subsequently, when an approved device is used |
| that, "One of the advantages...is that the incidence | | | | for anything other than its FDA approved |
| of adverse affects is substantially lower than that | | | | indication, it is called off-label. |
| of many drugs or other accepted medical | | | | MCS therapy for the treatment of retinal disease |
| procedures used for the same conditions." | | | | is considered an off-label use. |