mHealth Regulatory Coalition (MRC)
See the following -
FDA Won't Regulate Medical Device Data Systems
Draft guidance published Friday by the U.S. Food and Drug Administration seemingly paves the way for smoother medical device interoperability by lowering the burden on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
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 »
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mHealth Regulatory Coalition Urges FDA To Release Final Apps Guidance
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 »
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