MEDICAL DEVICE CLINICAL TRIALS

Clinical trials for medical devices have similarities to those for pharmaceuticals, however, they're unique as they're designed to support a "reasonable assurance of safety and effectiveness" for the marketing application and they're focused on safety. A medical device, per The Section 201(h) of the Food, Drugs and Cosmetics Act, defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or by being metabolized. These devices can be as simple as a tongue depressor or a thermometer or as complex as robotic surgery devices. Medical devices may be initially conducted in a "pilot" (smaller) population with the disease or condition being studied. Below are some examples of generic medical devices: