Tag Archives: FDA

FDA Calls For Classifying Health IT Products By Patient-Safety Risk Level

Posted on by Frank J. Rosello

The Food and Drug Administration proposed regulating health information technologies based on their potential risks to patient safety, rather than by the technology platform they utilize. The federal agency stayed close to recommendations made by stakeholders when developing the outlining … Continue reading

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In The Spotlight – Medical Apps Regulation

Posted on by Frank J. Rosello

The number of medical apps available to doctors and patients alike is growing continuously. The FDA has made its intention to regulate some medical apps clear, but less clear is which apps will and will not be regulated. Recently, two … Continue reading

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The FDA Announces Public-Private Partnership to Expedite Medical Device Approvals

Posted on by Frank J. Rosello

The U.S. Food and Drug Administration (FDA) announced Monday that it is part of the first public-private partnership to promote medical device regulatory science. The partnership will focus on speeding up the review and approval processes of new medical devices. … Continue reading

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Environmental Intelligence Releases July 2012 Newsletter

Posted on by Frank J. Rosello

Environmental Intelligence LLC is pleased to release its July 2012 EI Connections Newsletter.  Please send your feedback or suggestions to [email protected]. Click Here to view: July 2012 EI Connections Newsletter Want to automatically receive our monthly newsletter?  Click on this link to … Continue reading

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FDA Proposes Unique Device Identifier For Medical Devices

Posted on by Frank J. Rosello

In an effort to improve adverse events reporting, the U.S. Food and Drug Administration (FDA) has proposed that most medical devices distributed in the United States carry a unique device identifier (UDI). A UDI system has the potential to improve … Continue reading

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