As Omicron ravages the planet, it seems like Dr. Anthony Fauci is right in suggesting that the coronavirus will never completely go away. Even so, the current COVID-19 public health emergency (PHE) will have to end at some point. When that day comes, producers of tests detecting the SARS-CoV-2 virus will no longer be able to rely on US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to bring their products to the market. With that in mind, the agency has released draft guidance on making the transition from EUA to full marketing and regulatory approval. SARS-CoV-2 tests travel the EUA pathway Because SARS-CoV-2 was a totally unknown virus, there were no tests designed to detect it when the PHE began. As a result, FDA authorized, and continues to authorize, SARS-CoV-2 tests on an emergency basis using its authority under Section 564 of the Food, Drug & Cosmetics Act. Since the PHE began, more than 300 SARS-CoV-2 diagnostic products have reached the US market via the EUA pathway. Under the act, EUA authorization remains valid for as long as the PHE that prompted it remains in effect. So, if the virus is still around when some form of normalcy […]