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:
- 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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