April 14, 2020

FDA Diagnostic Testing Updates

In mid-March, the FDA updated regulations to expedite the delivery of diagnostic tests for COVID-19, allowing states to set up a system in which laboratories developing tests can engage directly with the appropriate state authorities, instead of with the FDA. Furthermore, the FDA does not intend to object to commercial manufacturers distributing these newly developed tests.

The FDA is also utilizing their power of Emergency Use Authorization (EUA), a system in which they may allow the use of unapproved medical products or unapproved uses of approved products in a crisis when there are no adequate or approved alternatives. Currently the FDA is working with over 300 developers in the hope of granting EUAs for diagnostic tests to detect COVID-19, with 34 such tests receiving EUAs.

Several COVID-19 tests are being utilized; some take days, hours, or minutes, but they employ different methods. An antibody test has recently been approved. However, the FDA has reiterated again and again that at this time, no at-home diagnostic tests exist for COVID-19. Any product claiming to do so is fraudulent, and the FDA is currently investigating such products.

Further developments are available on the FDA’s Press Announcement page.

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