Pharma Marketing Blog: FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices
"CDRH [FDA's Center for Devices and Radiological Health] does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act," says a new guidance posted today on the FDA website ("General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff").
Note: There is no "2." in the algorithm, but I assume it's the last paragraph. In any case, the examples cited by the FDA may better illustrate FDA's thinking. Three out of 4 of these examples involve mobile apps:
Illustrative Example 1: A mobile application plays music to “soothe and relax” an individual and to “manage stress.”
These claims relate only to relaxation or stress management, not to any disease or medical condition, and thus are general wellness claims. In addition, the technology to play music does not present inherent risks to a user’s safety. Therefore, this product meets both criteria for a low risk general wellness product.
CDRH’s general wellness policy does not extend to devices that present inherent risks to a user’s safety.
Whether a device is low risk for purposes of this guidance is determined by whether or not the product:
is invasive;
involves an intervention or technology that may pose a risk to a user’s safety if device
controls are not applied, such as risks from lasers, radiation exposure, or implants;
raises novel questions of usability; or
raises questions of biocompatibility.
If the answer to any of these questions is yes, the device is not a low risk general wellness product and is not covered by this guidance.
Some see a future battle on what is & isn't low-risk. "If it's up to companies everything will be low-risk," said Moira Gunn (@biotechnation) on Twitter.
FDA clarifies what apps don't require review: Stress management, activity and food tracking, as examples.