Finally, FDA Reveals Its Regulation Plans On Mobile Health Apps

[] Mobile health developers have been waiting for more than two years to get some clarity on how and what the US Food and Drug Administration (FDA) plans to regulate regarding mHealth apps. has finally released its final guidelines its guidelines after more than two years of issuing its draft guidance on the focusing on the various regulations around mobile health apps.

Today, there are approximately 40,000 mHealth related apps available for download on iPhone, Android and other smartphones. But most of these apps were developed outside the scope of FDA regulation. With the release of final guidelines, mobile health developers can now align themselves with agency’s regulation plans. Continue reading