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The updated rule allows companies to develop and distribute the tests after validation while an emergency use authorization is being prepared for submission.
The U.S. Food and Drug Administration (FDA) has updated the guidance on antibody testing for the COVID-19 coronavirus.
According to a news release, the revised rule allows laboratories and commercial manufacturers to help accelerate the use of tests they develop to expand rapid testing capacity. The rule allows companies to develop and distribute serological, antibody, tests after validation while an emergency use authorization (EUA) is being prepared for submission to the agency.
The revised rule will only be in effect while the current public health emergency is in effect. Due to the nature of the revised rule and the current pandemic, the rule was implemented without public comment, the release says.
In another release, Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD, gave insight into the updated rule.
They say that the revised rule outlines certain expectations for antibody test developers such as commercial manufacturers must submit EUA requests, along with their validation data, within 10 business days from the day they notified the FDA of their validation testing or from the date of this policy and specific threshold for specificity and sensitivity for all serology test developers.
The FDA also introduced a more streamlined process for EUA submissions and review including two voluntary EUA templates for antibody tests, the release says.
Shah and Shuren say that initial rules on serology tests from mid-March were intended to provide regulatory flexibility for test developers given the current emergency, but the guidance presented an opportunity for some unscrupulous actors to market fraudulent test kits.
“When we become aware of these issues, we have and will continue to take appropriate action against firms unlawfully marketing their tests, for example, by detaining and refusing illegitimate test kits at the border,” they say in the release. “The FDA is continuing to provide updated information and educational materials to states and health care partners.”