WASHINGTON —The FDA has posted a list of Covid-19 antibody tests that it has removed from its list of “tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.”
The list of antibody tests being removed is located under the document FAQs on Testing for SARS-CoV-2 and are listed under the question “What commercial manufacturers of serological tests had previously provided notification to FDA under the policy outlines in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list? (new 5/21).” The antibody tests listed were removed because they either did not meet the agency’s guidance of submitting an emergency use authorization (EUA) request or did not rectify problems found with the test in a timely manner, the FDA noted.
On May 4, the FDA tightened its restrictions on antibody tests to ensure that manufacturers followed its EUA guidelines and met specific performance thresholds before products are available on the market.
Moving forward, the agency said it will continue to update its removal list. So far, 27 antibody tests are on the removal list.
“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” said FDA Commissioner Stephen M. Hahn, MD, in a statement. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,791,932,190,926,151,725,928,925,934