How to get FDA approval?
The Food and Drug Administration (FDA) is the United States body responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. When targeting the US market, the first hurdle to consider is the lengthy and arduous process of medical device registration with the FDA.
A medical device company will choose the appropriate regulatory pathway depending on the risk class of the device. In some cases a device may be exempt from registration with the FDA.