Mobile Medical Apps & General Wellness Low Risk Devices

What is a Mobile Medical Application (Mobile Medical App)

FDA Guidance on Mobile Medical Apps defines a mobile application or “mobile app” – as a software application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform but is executed on a server.

Mobile medical app is a mobile app that meets the definition of in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and either is intended:

  • to be used as an accessory to a regulated medical device; or
  • to transform a mobile platform into a regulated medical device.

What are General Wellness Low Risk Devices in FDA?

FDA defines general wellness products as products that are intended for the general wellness use and present a very low risk to the users’ safety.

In order to qualify as low risk, the product must not be:

  • invasive;
  • involve an intervention or technology that may pose a risk to users’ safety (such as lasers, radiation exposure, or implants);
  • raise novel questions of usability; or
  • raise questions of biocompatibility.

FDA proclaims that it does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements and implementing regulations such as:

  • registration and listing and premarket notification requirements;
  • labeling requirements;
  • GMP requirements and
  • Medical Device Reporting requirements.

In a nutshell – low risk general wellness products are basically “regulation-free”.

See our blog about Mobile Medical Apps & General Wellness Products here.


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