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FDA Passes On Regulations For Wearables
- FierceHealthcare, Wednesday, August 3, 2016 9:05 AM
General wellness apps and devices won’t face tough FDA scrutiny, as long as they only promote general wellness and present a low risk to the safety of those who use them. In final guidance on the tools, the Food and Drug Administration says the Center for Devices and Radiological Health “does not intend to examine low-risk general wellness products.” Those products include wearables, apps, video games and software programs. Epstein Becker Green health attorney Brad Thompson, who had previously commented toFierceHealthIT on the draft guidance, said in an email the final version "strikes the right balance between regulation and innovation."
