Medical device

Common card · No. 206968

A medical device is any device intended to be used for medical purposes. In countries around the world, medical devices must be proven safe and effective before they are marketed. As a general rule, the higher the associated risk of the device the more testing is required to establish safety and efficacy. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States, it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated at all. It was not until later in 1976 that the Medical Device Amendments to the FD&C Act established medical device regulation...

Read on Wikipedia · Image Welleschik, CC BY-SA 3.0