FDA tightens rules on COVID-19 tests aimed at corralling bad actors

The FDA now expects COVID-19 antibody testmakers to submit requests for emergency use authorization of their assays within 10 days of test validation, backing away from its “highly flexible” stance in mid-March not requiring the application if the manufacturer notified the agency that it was selling the test and affirmed that it was validated and labeled as unapproved.

The FDA temporarily lowered the bar in order to facilitate nationwide access to testing but some opportunists have taken advantage of the situation with substandard products, including an electronics salesman hawking an unauthorized home test kit and a former doctor convicted in a fraudulent gold-peddling scheme.

In a statement, the agency says, “Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”

https://seekingalpha.com/news/3568338-fda-tightens-rules-on-covidminus-19-tests-aimed-corralling-bad-actors