FDA and mobile health apps

Posted on March 22, 2013


Here’s preliminary information about regulation of the 40,000 medical apps.  Hopefully, there will be enough regulation to make them safe and protect us from people that don’t at least know the medicine and the accuracy of their apps.

“The FDA has been regulating mobile medical device software for more than 10 years.  So far, the agency has reviewed 100 mobile medical apps, including remote blood pressure, heart rhythm and patient monitors, as well as smartphone-based ultrasounds and glucose meters.

The FDA focuses on those apps that meet the definition of a medical device according to the Federal Food, Drug and Cosmetic Act and are intended to be used as an accessory to a regulated medical device or turn a mobile platform smartphone or tablet into a regulated medical device.

Among those apps, there are three classes of apps that vary in potential risk and regulation requirements.The FDA does not intend to regulate apps that track a person’s daily steps, enable patients to refill prescriptions, search medical references, provide electronic health record services or offer similar services.

The FDA plans to issue final guidance on regulating medical mobile apps, Foreman said it would come before Oct. 1.”

for the full article check out “What mobile health app developers need to know about looming government regulation.”