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States can approve diagnostic tests during public health emergencies.

This act allows state authorities to approve and use diagnostic tests, like disease tests, without waiting for federal FDA approval, but only during a declared public health emergency. This means that in emergencies, such as pandemics, citizens can get faster access to needed tests as states can act independently. After the emergency ends, the FDA has 180 days to make a final decision on these tests.
Key points
States can independently approve diagnostic tests during public health emergencies, speeding up their availability.
The FDA cannot block the use of state-approved tests during an emergency, unless the state requests it.
After an emergency, the FDA has six months to decide on permanent approval for tests used by states.
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Additional Information
Print number: 117_S_152
Sponsor: Sen. Cruz, Ted [R-TX]
Process start date: 2021-02-02