FDA Compliance Alert: Mobile Medical Apps Need Complaint Management


Attention all Mobile Medical App developers and EMR/EHR providers: The FDA has decided to require their appoval for mobile medical applications. More specifically, apps that:

  • Act as an accessory to a regulated medical device,
  • Turn a smartphone or wireless tablet computer into such a device, or
  • Those that make recommendations regarding a patient’s diagnosis or treatment.

More information here.

If you are developing mobile medical applications that match the above description, you will want to:

  1. Wait to release it until the FDA releases the requirements and get FDA approval.
  2. Make sure you have in place a complaint management system in the event your mobile medical application has a problem, especially one that might impact patient or operator safety (No, Angry Birds isn’t on their list).

Along with approving medical devices and applications, the FDA does have a set of guidelines that can help you set up a complaint management system. (See this blog post.) 

Why is the FDA getting involved? The risk that these applications may impact how a medical device operates. Some mobile apps have already been cleared, such as those that allow physicians to view X-rays on their smartphones. But with over 200 million medical apps already out there and as many as 600 million by the end of next year, I hope the FDA is ready to burn the midnight oil to get the approvals out.

These apps have definitely helped the practice of health care and that is a capability we don’t want to see go away.


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