FDA Clamps Down On At-Home Coronavirus Testing, Citing Fake Products and Bad Actors
03/24/2020
After telling companies, laboratories and state health departments to move forward with emergency coronavirus testing without federal oversight or approval, the FDA is now working to rein in the ones it describes as going too far, according to a report in FierceBiotech.
To boost the nation’s access to much-needed diagnostics, the agency allowed certain certified laboratories and manufacturers to proceed with their own clinical tests for COVID-19—provided they validate the tests themselves and submit their data and official applications to the FDA within 15 days for review.