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FDA Announces Public Workshop On mHealth App Regulation to Gather Industry Input
It was announced today the FDA is planning a public workshop on September 12th and 13th to gather input on the recently issued draft guidance document “Mobile Medical Applications,” that aims to inform...
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mHealth Regulatory Coalition Wants to Help FDA Classify Healthcare Apps With...
It seems as though the entire mobile healthcare industry is waiting on the FDA to finalize its classification of mobile medical apps, and now the mHealth Regulatory Coalition (MRC) has developed a tool...
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mHealth Regulatory Coalition Says FDA’s Intended Use Approach for Mobile...
The FDA has had plenty of input as it works to draft guidelines for regulating mobile medical apps, but the mHealth Regulatory Coalition (MRC) in particular has maintained a leading voice since the...
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mHealth Regulatory Coalition Asks FDA to Revamp and Republish 2nd Draft of...
The mHealth Regulatory Coalition (MRC), who has been very vocal in terms of the guidelines being proposed for mobile medical apps, has asked the FDA to revamp and republish its proposed guidelines —...
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Republicans Urge FDA & FCC to Move Faster on mHealth App Approvals
In a rather interesting move, it’s been revealed that Republican House members are urging both the FDA and FCC to move faster in approving mobile medical apps. In a letter sent to both agencies last...
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