FDA Regulation of Mobile medical apps and cybersecurity

Overview:

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than just testing performance.

Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app design will be explained.

Areas covered in this session:

• What mobile apps are medical devices
• What mobile apps will be regulated by FDA
• How to get a mobile app approved by FDA
• Cybersecurity for mobile apps explained

Why should you attend?

The FDA has released a Guidance explaining how they intend to apply their regulatory authority to software applications intended for use on mobile platforms. 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. 

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements. The FDA approval process for a new app will be explained including FDA  software validation requirements which are more extensive than just testing performance.

Cybersecurity is very important for mobile apps. The FDA requirements for cybersecurity in the app usage will be explained.

Who will benefit?

• Development Engineers
• Production Management
• QA/ QC personnel
• Software developers
• IT personnel
• Legal dept