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FDA will not regulate most mobile medical apps

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5841 (Published 26 September 2013) Cite this as: BMJ 2013;347:f5841
  1. Michael McCarthy
  1. 1Seattle

The US Food and Drug Administration will leave most mobile medical applications unregulated while it focuses its oversight on apps that present the greatest risk of harming patients should they not work as intended, the agency said on Monday 23 September.

“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in a …

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