The FDA had allowed any manufacturer to sell their antibody tests after validating the results themselves and simply notifying the agency of its plans to sell.
The agency revised that policy May 4 and now requires manufacturers to apply for emergency use authorization within 10 business days after the product hits the market or the test won’t be allowed on the market.
On May 21, the FDA published a list of 29 tests that were either voluntarily withdrawn by the manufacturer or removed by the FDA because the manufacturer hadn’t applied for emergency use authorization.
The FDA said it expects the tests on the removal list will not be marketed or distributed and that it plans to continue to update the removal list.
Read the agency’s full news release here.
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