Digital Health Rules & Regs: An Overview of FDA Guidelines
This seminar will give an overview of FDA's approach to regulating mobile medical apps and software. Types of mobile apps/software that are not subject to FDA regulation will be reviewed. Guidance will be provided onhow to determine the risk level of your mobile app/software, and an overview of the regulatory requirements for testing mobile apps in human subjects will be provided. Participants are encouraged to bring a mobile device to participate in case scenarios.