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Senators want more clarity on mobile apps

April 7, 2014
by Richard R. Rogoski
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A bipartisan group of U.S. senators has sent a letter to the U.S. Food & Drug Administration (FDA) requesting more transparency and clarity in the organization's policy regarding the development of medical apps on mobile platforms.

The group, composed of senators Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner and Richard Burr, urged that the FDA not stifle the development of mobile app software while trying to keep the public safe.

Since the FDA issued final guidance for oversight of medical mobile apps in 2013, Congress has been seeking clarity on how current policies will affect innovation in this rapidly changing area of information technology.

"While the FDA’s final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated. We urge the FDA to work with Congress to identify policies that will serve the best interests of patients and innovators alike," the letter states.

The senators are also seeking information from the FDA on a number of issues:

  • Compared with current FDA guidance, what impact would Congress' legislating of medical software categories have on the FDA’s oversight of medical mobile applications?
  • How is the FDA determining what types of medical software updates, even minor updates, change the function of or add a function to the medical software and would require FDA review?
  • When a medical mobile application presents a novel function that has never been classified by the FDA, what procedures are used to determine if and how that application should be regulated by the FDA?
  • How has the FDA been coordinating with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission to address the recent FDA Safety and Innovation Act working group’s concerns over interoperability?
  • What approach does the FDA use to regulate complex medical software with multiple and separate functions?

The FDA is expected to reply within three weeks.