FDA updates authorization templates for asymptomatic, pooled testing; revokes antibody test

The Food and Drug Administration yesterday issued updated templates for laboratories and manufacturers requesting emergency use authorization for molecular diagnostic tests that screen asymptomatic individuals for SARS-CoV-2 or use pooled samples. The updated templates outline the validation expectations for these testing options.

“The FDA recognizes that organizations may want to conduct screening of asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students and others,” the agency said. “In addition to these template updates, the FDA has made available FAQs with information regarding tests for screening asymptomatic individuals.”

In other news this week, the agency:

• revoked the EUA for a SARS-CoV-2 antibody test made by Chembio Diagnostic System Inc. due to performance concerns with the accuracy of the test.
• posted FAQs and resources on reporting adverse events for medical devices under COVID-19 emergency use authorizations or other posted guidance.