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: