The Era of the Mobile App is Upon Us!
This memorandum covers developing FDA regulations of Mobile Apps. To a
great extent, the future of internet communication is via Apps. Some
estimate that 80% of internet traffic will be Mobile App mediated by the
end of the decade.
Bottom Line: The time to enter the Mobile App space may be now…
FDA Regs on Mobile Apps
Some of the questions being considered by the regulators:
- How the FDA should categorize mobile apps and decides how, or whether, to regulate them as medical devices.
- How the FDA evaluates an app's "intended use."
- How to interpret the FDA's promise of "enforcement discretion" for certain types of apps.
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