FDA Issues Mobile Medical Application Final Guidance

FDA Issues Mobile Medical Application Final Guidance

FDA released a Final Guidance today on Mobile Medical Applications.

Physicians and consumers are increasingly using mobile devices for healthcare purposes. The agency has indicated that it will have a tailored approach and “focus on the minority of apps that pose the higher risk to patients and and will exercise discretion for the majority that pose minimal risk to consumers.”

When evaluating mobile medical applications FDA will use same standards and risk-based assessment as for other medical devices.

FDA Press Release:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.htm

Official Guidance Document:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

History

We’ve been tracking this guidance since the draft was issued in July 2011.

The FDA received more than 130 comments including those submitted by the Coalition for 21st Century Medicine http://federal.eregulations.us/rulemaking/document/FDA-2011-D-0530-0084

Scope

The FDA did limit the scope of the final guidance document and clarified that:

This guidance does not address the approach for software that performs patient-specific analysis to aid or support clinical decision-making.   

This limitation is important to laboratories who are developing laboratory developed tests (LDTs) and provide web-based online tools to aid physicians in making clinical decisions.

To date, the FDA has cleared approximately 100 mobile medical apps, about 40 of those in the last 2 years.

In the guidance, FDA gives examples of the types of applications they may regulate and provides a process by which mobile application developers should reach out to the FDA regarding the mobile applications they are developing.

The FDA defines a Mobile Medical Application as one that is intended either:

  • to be used an an accessory to a regulated medical device
  • to transform a mobile platform into a regulated medical device

It is the “intended use” that determines whether the mobile software meets the definition of a “device” — for example, if the system is intended for the diagnosis of disease, or the treatment of a disease, it is a medical device regardless of the platform it is run on (desktop, smartphone, iPhone, tablet, etc.)

 

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