FDA won’t regulate these mobile apps

FDA LogoThe FDA final guidance lists several types of apps that may meet the definition of a medical device, but that pose lower risk to the public and will not be regulated. That should free developers to innovate and allow useful consumer products to come to market more quickly while ensuring that the mobile health apps are not only convenient, but safe.

The following list of apps (from mobihealthnews) highlights the 21 types of apps that the FDA called out in their guidance, saying it “understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps.” The agency says this list is not assumed to be or meant to be exhaustive, but rather is intended to provide some clarity.

  1. Some Psychiatric Apps (e.g. Moodhacker)
  2. Some physical therapy apps (e.g. Microsoft Kinect)
  3. Some drug interaction apps for consumers (e.g. myCVS)
  4. Some medication tracker & reminder apps (e.g. Mango Health)
  5. Some blood pressure tracking apps (iHealth Withings both have free companion apps)
  6. Some prediabetes, prevention focused apps (e.g. Omada Health)
  7. Some symptom navigator apps (e.g. WebMD)
  8. Symptom navigators that lead to provider locations and suggestions (e.g. iTriage)
  9. Reminder apps for pregnancy, smoking and more (e.g. BabyBump)
  10. GPS-enabled asthma management apps (e.g. Propeller Health)
  11. Other asthma management apps (e.g. Asthma MD)
  12. Preventative screening apps from established medical sources (Henry Food Health System)
  13. Apps that record clinician conversations with patients and make them available later (e.g. JiffPad)
  14. Nurse hotline apps (e.g. Live Nurse)
  15. PERS apps (e.g. Life Alert)
  16. Tethered PHR apps (e.g. OnPatient)
  17. Apps that provide display trends in personal health incidents (no example)
  18. Certain oral hygiene apps (e.g. Oral-B)
  19. Certain addiction-related apps (e.g. iPromises)
  20. Many fitness & wellness apps (many, including MyFitnessPal, RunKeeper and Azumio)

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