Home > FDA, research > FDA Releases Draft Guidance on Mobile Medical Applications

FDA Releases Draft Guidance on Mobile Medical Applications

Earlier today, the U.S. Food and Drug Administration’s (FDA) released draft guidance regarding the agency’s potential thinking on mobile medical applications. The draft discusses the circumstances under which a mobile app would be a regulated “device,” and how the agency intends to view and regulate various types of mobile applications.

FDA staff will hold a stakeholder teleconference and Twitter chat to discuss this topic later this afternoon. A replay of the teleconference will be available until July 26 by dialing 888-568-0616 or 1-402-998-1519.

The public comment period will be open for 90 days following the future publication of the draft guidance in the Federal Register. If you would like to comment and/or provide input to the ACR IT and Informatics Committee, please contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at 202-223-1670.

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Categories: FDA, research
  1. October 19, 2011 at 4:04 pm

    The FDA should regulate any medicinal technology and supplements in order to help avoid unnecessary complications that may manifest in unregulated devices and medicines.

  1. March 19, 2013 at 1:23 pm

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