Mobile Health Technology: Its A Phone, Its An App, And it's A…Medical Device?

As mobile health technology has proliferated, federal regulatory authorities have taken notice. In particular, over the last five years the U.S. Food and Drug Administration (FDA) has been honing its approach to mobile apps and has released a series of documents that provide helpful guidelines to developers of healthtech apps. In particular, the FDA sorts mobile apps into three buckets:apps that are not “medical devices,” and so are not subject to the Federal Food, Drug and Cosmetic Act (the FD&C Act);apps that are medical devices, ostensibly subject to the FD&C Act, but that pose a low enough risk to the public that the FDA has determined not to enforce the FD&C Act with respect to them; andapps that are medical devices, subject to the FD&C Act, and over which the FDA intends to apply its regulatory authority.

See it on Scoop.it, via Digital Health

from Digital Health | Scoop.it http://www.scoop.it/t/health-care-social-media/p/4067764047/2016/08/19/mobile-health-technology-its-a-phone-its-an-app-and-it-s-a-medical-device
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