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

Jun 17, 2020 - 02:58 PM
FDA-guidance

The Food and Drug Administration yesterday issued updated templates for and 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.

鈥淭he 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,鈥 . 鈥淚n addition to these template updates, the FDA has made available with information regarding tests for screening asymptomatic individuals.鈥

In other news this week, the agency:

  • 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 and resources on reporting adverse events for medical devices under COVID-19 emergency use authorizations or other posted guidance.

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