Wednesday, October 21, 2015

Classification of medical devices by FDA

In the US, the Food and Drug Administration (FDA) regulates any apparatus involved in diagnosing or treating disease.

While we were working on an IoT enabled Diabetes Management Solution, we learned that the FDA classifies all medical devices into 3 categories  - Class 1 / Class 2 & Class 3.

  • Class 1 devices are low risk devices and have minimum regulatory control. For e.g. dental floss, lancets, etc.  These devices must be listed in the FDA's medical device registry, but do not have a stringent approval process. 
  • Class 2 devices have higher risk and need stronger regulatory controls. For e.g. blood glucose meters, test strips, insulin pumps, etc. 
  • Class 3 devices have the highest risk and therefore have the highest level of regulatory control. For e.g. heart valves, continuous glucose monitors, artificial pancreas, etc.