FDA Signals to Most Mobile Apps/Wearable Devices That it Won't Regulate Them

Sunday, February 1, 2015

Source: Regulatory Affairs Professional Website

Will the US Food and Drug Administration (FDA) ever regulate your FitBit, Apple iWatch or calorie-tracking mobile apps? Almost certainly not, the regulator confirmed today in a new draft policy document covering all "low-risk" general wellness devices.

The guidance document, General Wellness: Policy for Low Risk Devices, explains that FDA's medical device regulator, the Center for Devices and Radiological Health (CDRH), "does not intent to examine low risk general wellness products to determine whether they are devices [under federal law] … or whether they comply with the premarket review and post-market regulatory requirements for devices."

Ordinarily, products classified as medical devices either need to be approved by FDA or need to show that they are highly similar to an existing device (the premarket notification process) or that they comply with establish standards for the production of a device (such as a band-aid)

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