WASHINGTON (AP) — U.S. regulators are revising a policy that has allowed coronavirus blood tests to reach the U.S. market without first providing proof that they worked.
The move Monday by the Food and Drug Administration follows criticism that the lack of oversight created a Wild West of unregulated tests.
Under the new policy, companies with tests kits for sale will be required to submit information on their test's accuracy within 10 days.
The blood tests are designed to show who has had a coronavirus infection in the past and may have some immunity.
Most use a finger-prick of blood on a test strip.
