Online Conference on FDA Device Software Regulation

29 July 2014, Fremont, United States

Introduction

FDA's risk classification will gradually clarify how it intends to manage the health risks. Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, mobile medical "apps," home use and remote use. Another growing concern is the public's use of software programs to manage their health issues rather than go to a healthcare professional.