On Wednesday representatives of the U.S. Food & Drug Administration testified before Congress that the regulatory agency ought to have a greater role to play in the approval of mobile medical apps for smart phones that do the job of a medical device that requires FDA clearance or approval.
According to Christy Foreman, Director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, the agency's app approval would be limited to those apps that are intended for use:
- - to transform a mobile device into a medical device already regulated by the FDA
- - as an accessory to a medical device already regulated by the FDA
There are currently several such apps on the market that meet these criteria, including apps that:
- - perform an ECG
- - control the delivery of insulin
- - work like a stethoscope
- - take patient-specific information, and then provide clinicians with radiation dosage calculations
- - allow doctors to view X-rays or other imaging
Therefore, should any of these or future apps malfunction or simply not work very well, they become a serious public health concern, and the agency believes it should be a part of the regulatory process.
For at least a decade, Foreman's office, the FDA's Center for Devices and Radiological Health, has been reviewing mobile medical apps. In that time, they have reviewed more than 100 applications and they have managed to keep the review process down to 60 days for completion.
The FDA will release a draft guidance soon, outlining a risk-based and narrowly focused approach to reviewing these kinds of apps. This draft guidance will help app companies determine whether or not their product will need to go through the review process.