When the FDA posted draft guidance on medical smartphone apps in 2011 it kicked off what was supposed to be a three-month consultation period. Two years and 142 comments later, FDA has returned with final guidance.
The upshot of the guidance is most app makers can continue to push out their products without worrying about FDA regulation. The FDA will only step in when apps stray into areas that convert mobile devices into tools the agency traditionally regulates as medical devices. If your app turns an iPad into an electrocardiograph (ECG), FDA regulations apply. But the hordes of calorie counters, drug adherence reminders and basic clinical practice calculators are off limits.
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly. It's not about the platform. It's about the functionality. An ECG is an ECG," Dr. Jeffrey Shuren, director of FDA's medical device division, told reporters on a conference call attended by Reuters. The approach is intended to focus FDA resources on high-risk areas. A faulty calorie counter is annoying. A faulty ECG is dangerous.
The guidance was well received. "This is very welcome news for the innovator and investment community," West Health Institute's Dr. Joseph Smith told The New York Times. Smith believes clearly demarcating the apps FDA will scrutinize will spur development. So far, FDA has only approved a small pool of apps that work as medical devices. The vast majority of developers have focused on areas outside of regulatory scrutiny, such as Johnson & Johnson's ($JNJ) mobile health manager Care4Today, which was updated this week.