The health agency had initially released draft guidelines more than two years ago in which it revealed that it will be regulating any mobile app which is deemed to be a medical device. After publishing the final rules, the FDA said that it will be focusing only on those apps which have the potential to harm consumers if they do not function properly.
The agency added that it will be regulating only those apps that will turn smartphones into devices that the agency currently regulates. For example an app that transforms a smartphone into an electrocardiography (ECG) machine will come under the new rules.
"Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA's tailored policy protects patients while encouraging innovation. It's not about the platform. It's about the functionality. An ECG is an ECG", the director of the FDA's medical device division, Dr Jeffrey Shuren said.