Is this a medical device?

Ed Panek

Ed Panek

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#1
#1
Imagine a smart phone based application that collects measurements from other cleared medical devices and presents them together for viewing. Does that require FDA Clearance?
 
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#3
#3
I would think it depends on the intended use of the application. For example,
- If you are providing access to electronic copies of data, you are not a medical device. (i.e. Lab Information Systems)
- If you are using the information for general fitness, health and wellness, you are not a medical device. (i.e. step tracker)
- If you are gathering data on a tablet so Health Care Providers can easily monitor vital signs, you are a medical device.

Reference: Examples of Software Functions That Are NOT Medical Devices
 
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