Home > FDA > FDA to Issue Guidance on Mobile Medical Applications

FDA to Issue Guidance on Mobile Medical Applications

The U.S. Food and Drug Administration (FDA) will formally issue its guidance for industry and staff regarding FDA oversight of “Mobile Medical Applications (MMAs)” on September 25. The guidance document is currently available to download on FDA’s website.

The American College of Radiology (ACR) IT and Informatics Committee, represented by Dr. David Hirschorn, participated in a 2011 FDA workshop on the draft version of the guidance. The FDA’s internal process to finalize the guidance was held back as a result of the issues surrounding the FDA Safety and Innovation Act of 2012 (FDASIA), including the establishment of the FDASIA Workgroup to provide recommendations to FDA, the Office of the National Coordinator for HIT, and the Federal Communications Commission on a risk-based regulatory framework for HIT and mHealth. The FDASIA Workgroup’s recommendations were submitted to the three agencies following approval earlier this month, which opened the door for publication of the long-awaited final version of FDA’s MMA guidance.

Categories: FDA
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