Digital Health Rules & Regs: An Overview of FDA Guidelines
Join the Mobile App Gateway and the Office of Regulatory Affairs and Quality for a seminar on Digital Health Rules & Regs: An Overview of FDA Guidelines on March 20th, 9:00AM-10:00AM. 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 on how 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.
Light breakfast will be served.