[bravo22]

The testing is NOT skipped. This is a misunderstanding of 510(k).

The device still has to go through testing, validation and verification. It is a very detailed process and follows IEC spec. The device also needs IEC 60601 testing by a third party lab. In this case at least 60601-2-24.

The 510(k) means it is not doing something new therapeutically therefore it doesn't need to go through PMA process which so much longer and more complex. In this instance they're saying a pump that uses electronics to monitor and deliver glucose already exists. Our device does the same thing therapeutically but we do it differently and here is all out docs showing the device is safe.

If they came up with a magical patch that used quantum chemtrail energy to align the shakras and thereby affect the patient's insulin levels, then they would need to go through PMA and show the therapy is safe and works in small clinical trials followed by larger trials before they can make a device that can be marketed.