March 1, 2020: The FDA took new steps to expand testing for the coronavirus by allowing certain hospital laboratories in order to use their own tests before being cleared by the agency.
The action followed the complaints from academic medical centres that the previous policy — which required previous approval of the lab tests — was too heavy, too slow and also holding back efforts to diagnose patients.
Experts have warned that the small number of U.S. cases so far may be a reflection of the limited testing, not of the virus’s spread. Testing has been delayed because of problems, now being corrected, involving the only test that had been cleared by the FDA, one created by the Centers for the Disease Control and Prevention.
Certified hospital laboratories will usually establish their own in-house tests, but the rules of a public health emergency — which now regulate coronavirus outbreak — ensure that these tests need the FDA’s “authorization for emergency use.” Under the policy announced Saturday, the laboratories will start using their own tests after validating them and before the FDA has completed their evaluations.
Therefore, hundreds of labs could soon begin testing thousands of patients.
http://fda.einnews.com/article/510939576?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D
