Developing valid tests far easier than getting approval?
Developing the coronavirus test was easy for most labs; however, getting approval from the FDA and CDC was not as easy. Initially, the FDA required private labs to duplicate the CDC’s test design and have the agency review their tests before they could begin administering them. It took more than three weeks and growing public criticism for the FDA to update its guidelines to allow certain labs to start testing once they had validated their tests internally.
The FDA loosened its regulations on February 29, allowing clinical labs to test for coronavirus using tests they developed and validated. However, they were required to notify the FDA and submit EUA requests within 15 days. The FDA made additional changes on March 16 to enable broader testing, after weeks of pressure from labs across the country.
A spokesman for the CDC, Benjamin Haynes, acknowledged that “the agency’s quality control measures were insufficient during the coronavirus test development.” At the same time, the FDA also took a hit for not initially allowing private labs to begin ramping up production of their own tests.