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 Draft Guidance for Industry and Food and Drug Administration Staff").

Recall FDA's "Mobile medical apps Proposed Scope for Oversight" pyramid:

There are three parts of the pyramid:

1. The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices. 
2. The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion 
3. The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.

The guidance released today is an attempt to define the boundary between parts 2 and 3 of the pyramid and to clarify what FDA meant in a 2012 guidance when it said this:

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