FDA Mobile Medical Apps Draft Guidance

FDA issued “Draft Guidance for Industry and Food and Drug Administration StaffMobile Medical Applications” and the comment period ends 90 days from July 21, 2011. This guidance defines some of the types of mobile applications that will be regulated as medical devices and some of the criteria that will be used in making such determinations. It specifically indicates that companies that are only distributing them are not being regulated as device manufacturers (such as Android Market, Apple, etc.). In addition to a number of clarifications on what will be regulated as a medical device there is a statement that FDA understands that simply regulating apps like the devices they are accessories for may not be appropriate and they are looking for input. The full guidance is at the link provided.

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