Bloomberg Law
March 17, 2020, 1:01 AMUpdated: March 17, 2020, 2:02 AM

FDA Gives States Power to Approve Virus Tests Without Federal OK (2)

Jeannie Baumann
Jeannie Baumann

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 ...

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