mHealth Regulatory Coalition (MRC)

See the following -

FDA Won't Regulate Medical Device Data Systems

Dan Bowman | Fierce Health IT | June 20, 2014

Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements...

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mHealth Group Urges FDA To Publish Final Guidance

Eric Wicklund | mHIMSS | June 21, 2013

Some mHealth advocates are getting impatient with the U.S. Food and Drug Administration. The FDA released its preliminary guidelines for the regulation of mobile medical apps in late 2011, and since then the mHealth world has been awaiting the government agency's final document. Read More »

mHealth Regulatory Coalition Urges FDA To Release Final Apps Guidance

Greg Slabodkin | FierceMobileHealthcare | June 21, 2013

The mHealth Regulatory Coalition (MRC) on June 21 sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius urging HHS, through the U.S. Food and Drug Administration (FDA), to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible." Read More »