The FDA says apps that are an extension of medical devices will not require approval. For example the Nike+ app will not need FDA approval while the fitness band will. “This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices", stated the FDA. “We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
This is good news for the Apple Watch. The Wall Street Journal reports that a medical-device company DexCom is already developing an app for the Watch that will display blood glucose levels. These levels are read by its popular diabetes glucose monitor and then transmitted to the Apple Watch app, eliminating the need for FDA approval.
Tim Cook recently claimed that Apple Watch will make its way to the markets in April, with no specific date announced. Hopefully this new FDA ruling will encourage developers to create a plethora of Apple Watch extensions and embellish the future Apple device.