State health departments have the power to put Covid-19 tests on the market without waiting for FDA approval under a shift in policy announced by the federal agency.
The policy change gives states enormous responsibility for regulating new diagnostics that come online, a landmark move for the Food and Drug Administration to relinquish oversight over testing to meet testing demands.
Agency leaders acknowledged the policy released Monday means the FDA is taking a risk by relying on state public health departments. But they said the move was necessary to balance the needs of a pandemic with the risks the tests ...