The Food and Drug Administration regulates a broad range of medical devices, including complicated, high risk medical devices, like artificial hearts, and relatively simple, low-risk devices, as well as devices that fall somewhere in between, like the Indigo Biofeedback System. The FDA has authority to regulate medical devices before and after they reach the marketplace.

 

The INDIGO is listed as a Class II device with the Food and Drug Administration through the establishment registration of Quantum World Vision.

 

What does it mean for the FDA to "classify" a medical device?

• The FDA classifies medical devices based on the risks associated with the device.

• Devices are classified into one of three categories—Class I, Class II, and Class III.

• Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness.

• The Indigo Biofeedback System is classified as a Class II device.