SOFTWARE AS A MEDICAL DEVICE (SAMD) BASED ON ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING: THE PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA) PERSPECTIVE

Abstract

Rapid advances in artificial intelligence and machine learning technologies have revolutionized the software development domain. These technologies are also applied to software used as medical devices, such as computer-aided diagnosis (CAD) used in the field of gastroenterological endoscopy. Some CAD programs have received regulatory approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Further development of CAD is anticipated; and yet at the same time, regulatory issues associated with clinical implementation need attention. In this article, we present an overview of the current scenario with regard to regulatory approval by the PMDA for the application of software as a medical device.