Take the case of Alex Greninger, a doctor and researcher at the University of Washington, who, according to a report in GQ, submitted his application to create a coronavirus test via email. Then he learned that he also needed to submit a paper copy, and then another version burned to a compact disk or loaded onto a drive and delivered to the FDA’s Maryland headquarters.
After he complied, the FDA did not approve his test right away, according to a report in ProPublica. They asked him to make sure his test didn’t cross-diagnose with SARS and MERS, other coronaviruses which hadn’t been seen in the U.S. in years. His test was finally certified on February 29, at which point the fatal outbreak in his home state of Washington was already underway.
As the crisis worsened and the testing shortage drew headlines, the FDA simplified the process. But then on March 20, it shut down efforts to rapidly make available at-home testing kits on the grounds that they were unvetted and could be fraudulent.