FDA compliance of healthcare apps

Nowadays, Mobile healthcare apps have become the trend and growing use has led to FDA to exhibit control over them. As a first step developers need to determine if it falls into the medical device category or not, if they need to comply with the QSR guidelines.

Online tools have been designed by the US federal Trade commission (FTC) in order to help the developers of tele-health apps and mobile medical apps to determine which regulations apply to these. App developers who are not sure of compliance should utilize this tool to determine the law they need to comply to. This tool presents a series of questions to the developer to determine the law they need to comply to.

· Health Insurance Portability and Accountability Act (HIPAA

· Food, Drug & Cosmetic Act, enforced by the FDA

· Federal Trade Commission Act

· Health Breach Notification Rule

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking and USFDA. Contact jr@i3cglobal.com