Faculty: Edwin Waldbusser
This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA cybersecurity requirements. The FDA approval process for mobile apps will be explained including FDA software validation requirements which are more extensive than just testing performance.
The FDA Guidance explains how they intend to apply their regulatory authority to software applications intended for mobile medical apps. They have defined what types of apps they consider a medical device. Apps that are medical devices must meet all FDA device requirements, however, FDA will not enforce their requirements on mobile apps that meet the FDA’s definition of a medical device but pose a low health risk.
Areas Covered in the Session :
Who Should Attend: