RE: POLX - FDA8 Oct 2021 20:17
The FDA will be looking for potential mechanical and electrical failure's plus normal safety issues when using an electrical device. They will also test for contamination from regular use. For me the most important element is traceability of each Parsortix Plate from a diagnosis point of view, ensuring any retrieved cells are carefully notated and recorded to the correct patient.
Lastly, and this was discussed on this board, that there is security that the Parsortix Plates are always genuine products and not forged inaccurate copy's.
That's the Device side.
The FDA will also want to ensure that the medical claims made by Angle match up to their own investigative findings.
A positive FDA Approval will mean that the Parsortix System can be fully implemented in a hospital setting so it has to be fool proof, reliable and medically sound.
The FDA shoulders all the responsibility of that decision.
Chester.