Impact of FDA’s Final Guidance on Mobile Medical App Development


The U.S. Food and Drug Administration (FDA) issued its final guidance for mobile medical application development that is subject to FDA review. But mobile medical app development is subject to review ONLY when there is a greater risk to patients from medical mobile apps that do not work as intended, i.e. apps which pose minimal risk to consumers will not be enforced with requirements under the Federal Drug & Cosmetic Act.

As per Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, the agency is taking tailored approach that supports innovation while protecting consumer safety.

Will there be any possible impact on the mobile health market?
Now despite FDA’s attempt that encourages innovation by intending to exercise enforcement discretion for majority of medical mobile apps, 80% of the mobile health revenue market may still reflect an impact. This is because 80% revenue of mhealth market in 2013 is predicted to be covered by Connected Medical Devices comprised of cardiac monitoring, diabetes management devices, multi-parameter tracker, etc. (where connected cardiac monitoring devices has the maximum market share, followed by diabetes management devices, and multi-parameter trackers). Refer RNRMarketResearch

How does that relate to FDA Guidelines?
FDA intends to apply its regulatory oversight to mobile medical apps which can be comprised of

  • software programs that run on smartphones and other mobile communication devices OR
  • the accessories that attach to a smartphone or other mobile communication devices OR
  • a combination of accessories and software.

Having said that, sale or general consumer use of mobile devices (smartphones and tablets) or the mobile app distribution (by iTunes App Store and Google Play Store) does not fall under the regulation. Read in detail…

You can also seek our support for mobile medical app development or mhealth app development. Contact us here.


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