FDA's Commitment to COVID Testing

Stephen M. Hahn, MD; Jeffrey E. Shuren, MD, JD


January 19, 2021

Editorial Collaboration

Medscape &

As we start a new year, it is important to pause and reflect on what a challenging year 2020 was for so many — one that was filled with heartbreak and uncertainty due to a pandemic, the likes of which have not been seen in our lifetime.

As we remember the difficulties we've faced, and the challenges that remain, we would be remiss not to acknowledge the incredible scientific achievements that have been made this past year, whether that is the development of multiple vaccines in record-breaking time or the remarkable advancements that have been made in tests for the COVID-19 virus and tests for a person's immune response to it.

In less than a year, the US Food and Drug Administration (FDA) issued over 300 emergency use authorizations (EUAs) for COVID-19 tests. That's nearly one test every day during this public health emergency. FDA employees have worked around the clock to authorize accurate and reliable tests as quickly as possible, sometimes in as little as 24 hours or less.

While the numbers are important, we must acknowledge the role of FDA's EUA authorities and the critical flexibility they provide. During the prior six declared public health emergencies, the FDA used its EUA authorities to authorize diagnostic tests made by commercial manufacturers and laboratories. This pathway expedites access to tests during emergencies while enabling FDA to ensure that they are accurate and reliable, when information gaps and false results may adversely affect patient care and public health decision-making. This allowed for early COVID-19 tests to be developed, validated, authorized, and deployed in weeks rather than months to years, as in the case of the more rigorous evidentiary standard required outside a public health emergency.

This pandemic also created a demand for new tests that is unparalleled. The FDA has taken extra efforts beyond our typical role as a regulator to engage, since the earliest days of January 2020, with the diagnostic and public health ecosystem at large to help drive development of accurate and reliable tests. This has been done by providing regulatory flexibility through policies; closely working with test developers by offering recommendations on the scientific data that should be submitted to support authorization of their tests; practically open access to our scientists to ask questions and to request review of test data on a rolling basis; hosting weekly webinars; and supporting agile and creative policy development as the pandemic evolved.

As a result, the American public has access to a greater variety of tests to address a national emergency like COVID-19 than at any other time in our country's history. They include tests to diagnose COVID-19 or to look for antibodies to the COVID-19 virus, tests that can be performed in labs or at the point of care, such as a doctor's office or a pharmacy, often with results that can be provided within minutes. And more recently, we authorized tests that can be performed at home. Not surprisingly, making tests that are simple but accurate enough to be used by anyone is more complicated and time-consuming than making tests to be used in sophisticated labs. Yet, the speed with which tests have been developed and authorized is the result of tremendous advancements in science and the dedication of countless individuals.

Science also drives every decision we make. The FDA does not develop tests, nor can we specify how many are produced or where in the United States they are distributed. We also do not decide which test a healthcare professional uses or recommends. Our role is to determine whether the tests developed by others meet the criteria for authorization — meaning, that they produce results that Americans can trust. It's critical that the tests, particularly diagnostic tests, work, because false results can contribute to the spread of COVID-19.

That said, everyone must understand that even as far as we have come with COVID-19 tests, no test is 100% accurate. There is always a risk for false results, so it's important to continue to take steps to protect yourself and others by wearing a mask, washing your hands, and maintaining physical distancing. We're in this together.

As 2021 begins, the FDA is looking forward to continuing to support innovation in testing and providing support and flexibility to test developers with the goal of increasing the availability of accurate, reliable tests to all Americans.

Stephen M. Hahn, MD, is Commissioner of the US Food and Drug Administration, and Jeffrey E. Shuren, MD, JD, is director of FDA's Center for Devices and Radiological Health.

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