March 16, 2020 / 11:44 PM / 12 days ago

FDA giving states authority to approve own coronavirus tests, official says

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Monday took a step toward speeding the development of coronavirus test kits, agreeing a regulatory change to give states the ability to approve tests developed in laboratories in the states, an administration official said.

The regulatory relief came as President Donald Trump attempts to accelerate the availability of testing for the pandemic as the virus spreads deeper into the United States.

“The purpose is to achieve more rapid testing capacity in the United States,” said the official, who spoke to Reuters on condition of anonymity.

The new policy gives states the option to take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted last week to the New York state Department of Health, the official said.

“States can set up a system in which they take responsibility for authorizing such tests and laboratories won’t engage with the FDA,” the official said.

“Basically it’s just giving power to the states to control this process. The FDA will not be involved in the process. The states will take over the approval process. This is getting rid of bureaucratic red tape that will allow for the approval to be much quicker than would normally take place,” the official said.

Reporting by Steve Holland, Editing by Rosalba O'Brien

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