United States regulatory approval of medical devices and software applications enhanced by artificial intelligence

In the United States, regulatory oversight of medical devices has evolved with the changing technology. With the introduction into routine clinical practice software applications and computer-based devices, the U.S. Food and Drug Administration (FDA)has further defined categories of risk and intended use to better uphold patient safety, while encouraging innovation in medical technology. However, as new software technologies such as artificial intelligence (AI)are developed, refined, and introduced into the healthcare sector, there will be a need for regulatory bodies to rapidly respond. In the current review, we discuss the evolution of US FDA oversight of medical devices, initially of hardware, and the present stance on medical software applications, including devices augmented with artificial intelligence.