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Pharma Compliance Info FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices Digital

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

Recall FDA’s “Mobile medical apps Proposed Scope for Oversight” pyramid:
Pharma Compliance Info FDA Says It Will Not Regulate Low-Risk Mobile Health Apps as Medical Devices Digital
There are three parts of the pyramid:
– 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.
– 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
– The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.

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