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New Policy for SARS–CoV–2 Serology Tests

May 30, 2020  •  Blog  •  Cheng Zhang, Senior Consultant, Medical Devices
Posted In Medical Device News & Insights – Biologics Consulting  •  Tagged antibody, antibody test, EUA, serology

FDA significantly tightened oversight on SARS‐COV‐2 serology tests by publishing new policy requiring all
serology tests to be reviewed and approved under Emergency Use Authorization (EUA).
In a rush to make serology antibody tests available as quickly as possible, FDA previously allowed SARSCOV‐
2 serology test manufacturers to sell their products once they completed the validation and sent a
notification to FDA, without FDA reviewing the performance of the tests. There have been deceptive
marketing and inaccurate results with these tests. With this new policy, all manufacturers who have
been selling the products with the notification will need to submit an Emergency Use Authorization
(EUA) application to FDA within 10 days and FDA will review the performance data to make a decision
weather an EUA can be authorized.

Food and Drug Administration (FDA). (2020). Insight into FDA’s revised policy on antibody tests: prioritizing access and accuracy. Retrieved from source.