Frank Pallone actually said...

It is important that, as the committee considers this issue, we have a better understanding of the strengths and limitations of both FDA and...

We are also very concerned about this deemed-approved approach. It essentially says if we don't make it decision in time, it is approved.

It does not make sense to regulate tests differently based on who develops them.

Patients deserve to know that the test results they are relying on to diagnose or treat a condition is accurate.