What is FDA mHealth Regulations?

FDA mHealth regulations refer to the Food & Drug Administration’s (FDA) regulations on mobile health applications and software that generally collect, share and ensure access to health information. The FDA mHealth regulations fall on the following:

  1. A mobile health application which functions in a similar way to that of an FDA-regulated device,
  2. Health applications that are accessories to the regulated device
  3. Mobile health applications that help with diagnosis and treatment suggestions

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