Sep 30, 2019

The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions.

FDA’s final guidance replaces draft guidance issued in 2013, and aligns with requirements in the 21st Century Cures Act of 2016 for determining whether or not a digital health tool or product qualifies as a mobile medical device (and therefore as a medical device). The agency has also published updated guidances on related issues such as off-the-shelf software for medical devices and medical device data systems (MDDS).

The final guidance scope keeps longstanding definitions in place: telehealth products and technologies are considered mobile medical apps if intended for use either as accessories to other regulated medical devices or to transform mobile technology platforms into regulated devices.

Software falling outside the scope of the mobile medical app guidance

Now that FDA guidance on mobile medical apps has been updated according to new legislative requirements, the list of digital health products not considered regulated devices has grown. The agency identifies 21 software functions that fall outside the scope of the final guidance, including:

  • Tools for accessing electronic copies of medical textbooks and reference materials;
  • Software for healthcare providers to use in education and training;
  • General health and wellness apps;
  • Software to access electronic health records (EHR) systems or organize EHR data without changing prescribed treatments;
  • MDDS used for transferring, storage and/or display of medical information;
  • Software to transfer, store or display clinical laboratory test data or results.

Which digital health products do qualify as mobile medical apps?

Again, FDA criteria for which telehealth products fall under agency oversight as medical devices remains consistent in the final guidance:

  • Software to transform mobile platforms into devices;
  • Software that connects to devices in order to control their operations, functions or energy sourcing;
  • Software to analyze patient-specific device data as part of active patient monitoring.

Additional US FDA regulatory resources for mobile medical app developers:

  • US FDA 510(k) consulting for medical device companies
  • Regulatory consulting for telehealth and mobile medical apps
  • FDA medical device classification support
  • Whitepaper: Does your mobile app need FDA clearance?