Low-Risk Medical Apps Will Not Need FDA Regulation
Monday, March 2, 2015
Makers of health apps can breathe easier now that the FDA has outlined new standards for what does and does not constitute a digital medical device. The FDA will not enforce regulations for wearables that receive information from medical devices, the administration officially announced on Feb. 9. In a webinar on Feb. 24, they further clarified what a medical device is from a regulatory perspective, and which devices and apps will not fall under their jurisdiction.
MDDS (Medical Data Device Systems) were previously classed from I to III, with Class I devices subject to general controls. Since then, though, the FDA has gained more familiarity with those types of devices and decreed that they will not enforce compliance with MDDS devices, medical image storage devices, or medical image communications devices.
MDDS devices do not take any medical data themselves, but simply store, transfer, or display that data. For example, software that collects output and transmits it to doctors or a server would not fall under FDA jurisdiction. A MDDS does not modify data or control the functions or parameters of any medical device.