FDA names 28 antibody tests to be taken off the market
The FDA named 28 coronavirus antibody diagnostics it says should be taken off the market weeks after closing its open-door policy on COVID-19 blood tests and requiring developers to submit their products for review.
The FDA changed its policy May 4, giving test makers 10 days to submit applications for review. The agency expects its list of removed products to be updated in the future. The 28 tests include ones that were voluntarily withdrawn and those that neglected to pursue an official FDA Emergency Use Authorization.
