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Capitol Health Call
May 14, 2014

Seeking Clarity on FDA Medical Apps Oversight

Author Affiliations

Copyright American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(18):1847. doi:10.1001/jama.2014.5034

A bipartisan group of senators is seeking greater clarity and transparency from the Food and Drug Administration (FDA) regarding its policy overseeing certain mobile medical applications, or apps.

On September 23, 2013, the FDA issued its final guidance, saying it intended to not use its regulatory oversight for a majority of mobile medical apps, as they pose minimal risk to consumers. The agency did say it intended to use its oversight for medical apps that present a risk to patients if the apps do not work as intended.

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