4 ms·

The “substantially equivalent” approval loophole is a textbook example of regulatory capture: - approvals for version N + 1 are basically skipped, as is safety

by hedora 3y ago

The “substantially equivalent” approval loophole is a textbook example of regulatory capture: - approvals for version N + 1 are basically skipped, as is safety testing - manufacturers get a liability shield - for many classes of devices, ladder pulling implies that no one will ever get another v1 approved. (The current rules for that are impossible to meet, but the incumbent company is grandfathered in under the old rules).

bravo22 3y ago
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.
s1artibartfast 3y ago
It isnt capture. IT is the opposite. Capture is how first movers and established players raise the bar for others. the 510k process does the opposite. it means that the FDA has already reviewed devices of that nature for safety and efficacy, and you dont need to do a clinical trial, you just need to do the testing to correct your points: - No testing is skipped (just trials - There is no liability shield. I have no idea what you are talking about with ladder pulling. Do you have examples?

by hedora 3y ago

bravo22 3y ago

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.

s1artibartfast 3y ago

It isnt capture. IT is the opposite. Capture is how first movers and established players raise the bar for others. the 510k process does the opposite. it means that the FDA has already reviewed devices of that nature for safety and efficacy, and you dont need to do a clinical trial, you just need to do the testing to correct your points: - No testing is skipped (just trials - There is no liability shield. I have no idea what you are talking about with ladder pulling. Do you have examples?