For immediate release:

Today, the US Food and Drug Administration is taking several important steps in support of ongoing nationwide COVID-19 testing efforts. These actions aim to further increase access to accurate and reliable COVID-19 testing, especially diagnostic tests that can be performed at home or in places such as doctors’ surgeries, hospitals, urgent care centers and emergency rooms without being sent to a central lab. to try out.

“In addition to vaccination efforts, testing remains a cornerstone of the national response to the pandemic and plays a pivotal role in helping Americans return to work, school and other important activities, especially as the holiday season approaches. The FDA remains committed to helping increase the availability of tests that will have the greatest impact on the nation’s ongoing COVID-19 testing needs, such as home and point-of-care diagnostic tests that can be produced in high volumes. ” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “By focusing our assessment on these types of tests and ensuring that available tests are monitored appropriately, we can better respond to the pandemic as the country’s testing needs continue to evolve.”

To date, the FDA has approved more than 420 sample collection tests and devices that provide a wide variety of testing options. Since the start of the pandemic, the FDA has adapted its regulatory approach to meet the testing needs of the public and has worked closely with test developers to adapt as those needs have changed. These efforts have helped increase testing capacity and broaden public access to rapid tests, including those purchased over-the-counter (OTC). Recent FDA approvals alone could mean up to 400 million OTC tests per month will be available to U.S. consumers by early 2022.

Key Policy Highlights

Today, the United States Department of Health and Human Services repealed a policy that instructed the FDA not to enforce premarket assessment requirements for laboratory-developed tests (LDTs). This action helps ensure that COVID-19 testing is accurate and reliable.

The FDA also today updated its policies regarding tests, including LDTs, that are currently offered pre- or unapproved, as well as policies regarding the types of tests on which the FDA plans to focus its review.

In the future, the FDA generally plans to focus its review on Emergency Use Authorization (EUA) requests for the following types of tests:

  • Home and point-of-care (POC) diagnostic tests for use with or without a prescription and which can be manufactured in large quantities;
  • Certain large-scale, laboratory-based molecular diagnostic tests (and home collection kits for use with such tests) that increase testing capacity or accessibility, such as by pooling samples to increase throughput, testing samples collected at home and shipped to the lab, screening asymptomatic individuals or detecting multiple different respiratory viruses simultaneously;
  • Certain laboratory-based and high-volume POC antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and
  • Tests for which the request comes from, or is supported by, a U.S. government stakeholder, such as the National Institutes of Health’s Biomedical Advanced Research and Development Authority of Rapid Acceleration of Diagnostics.

Developers of other tests may consider pursuing marketing authorization through traditional device assessment methods, such as 510(k) notification or De Novo classification.

As discussed in the guidelines being reissued today, “Coronavirus Disease-2019 Testing Policy During the Public Health Emergency (Revised),” the FDA now generally expects newly offered COVID-19 testing, including LDTs, an EUA or traditional marketing will have an authorization, such as a De Novo or approved 510(k), prior to clinical use. As discussed in the previous COVID-19 testing policy, some developers offered their tests before or without an EUA after the test was validated and notified to the FDA. That policy was intended to speed up the availability of tests, but resulted in some underperforming tests being offered prior to FDA review. Importantly, the policy has never been applied to home or home pick-up tests. With that in mind, and given the number of authorized tests available, the FDA will discontinue this notification policy going forward. For tests currently offered without submitting an EUA request, the FDA generally expects the submission of an EUA request as described in the guidance. For such tests and notified tests with pending EUA requests, the FDA generally plans to review the EUA requests and, if the test is subsequently not authorized, expects developers to discontinue the test within 15 calendar days of notification.

In addition, the agency today issued an umbrella EUA for serial testing that includes certain lab-developed molecular diagnostic tests. These tests can be used to test at regular intervals as part of serial testing programs, such as those in places such as schools, workplaces, or community groups. The EUA umbrella efficiently authorizes certain tests to increase access to accurate and reliable molecular diagnostic tests.

The FDA will continue to provide support and expertise to help develop accurate and reliable tests and to facilitate access to testing for all Americans.

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The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.