Quote:
Originally Posted by blueash
It is not quite accurate that there are no restrictions on antibody tests being sold. The FDA announced that it would allow the manufacture and sale of tests for COVID on an emergency basis, not requiring the rigorous approval process usually demanded. The manufacturer must still request FDA approval and submit extensive documentation of the test procedure and quality. If the FDA is satisfied with the application then it approves the test on a temporary basis which will terminate when the emergency is over.
HERE is an example of the FDA granting emergency approval for a blood antibody testing device. You will see it is very specific on what criteria were met by the manufacturer to satisfy the FDA and what ongoing regulations and compliance are required. |
Thank you. It is so good to have a trustworthy person to keep us straight. This was a result of something I heard on Wesh about five nights ago. Oh I wish we had valid and approved sources and that the POTUS would keep his rhetoric separate from the medical experts. I felt the same way about the handling of the Ebola virus. People were at cross purposes without the information to guide. Thank you again, Dr. Blueash.