Wednesday, September 25, 2013

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:
  • to be used as an accessory to a regulated medical device; or
  • to transform a mobile platform into a regulated medical device."
You might also be interested in:
FDA's Press Release - FDA issues final guidance on mobile medical apps
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

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