The FDA Releases Final Guidance for mHealth App Developers

9-23-2013 10-03-55 PM

The FDA releases its long-awaited regulatory guidelines for the mHealth app market, bringing an end to uncertainty that was credited with both stalling innovation and dampening investment activity in the mobile medical app market.

The guidelines take a very hands-off approach to regulating the growing market, breaking its regulatory approach into two categories: apps that require premarket review, apps that likely do not require FDA review but will be subject to enforcement discretion.

The FDA will focus premarket review on any mobile app “intended to be used as an accessory to a regulated medical device”, or that “transform a mobile platform into a regulated medical device.” Examples of regulated apps include diabetes management apps like WellDoc’s Bluestar app, or ECG viewers like AirStrip.

The second class of regulation applies to apps that technically meet the definition of a “device” but pose minimal risk to patients or consumers. Some examples of apps that may incur discretionary regulatory enforcement:

  • Apps that attempt to diagnose psychiatric conditions such as PTSD or depression.
  • Apps that provide health coaching or education in support of chronic disease management or healthy pregnancy initiatives.
  • Apps that use games to motivate patients to complete physical therapy routines.
  • Apps that use GPS location to help patients better understand asthma or allergen triggers.

According to FDA guidance, apps in this class will not require regulation as long as they are not “marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Suggesting that marketing departments may hold the keys on whether their apps will require FDA regulation.

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