Today, the US Food and Drug Administration is taking several important actions to support ongoing national COVID-19 testing efforts. These actions are designed to further increase the chances of obtaining accurate and reliable COVID-19 testing, especially diagnostic tests that can be performed at home or in doctor’s offices, hospitals, emergency care centers, and emergency rooms without having to be sent to a central laboratory Used for detection.

“In addition to vaccination efforts, testing remains the cornerstone of the country’s response to the pandemic, and it plays a central role in helping Americans return to work, school, and other important activities, especially as the holidays approach. The FDA remains committed to helping. Increasing the availability of tests will have the greatest impact on the country’s ongoing COVID-19 testing needs, such as home and point-of-care diagnostic tests that can be mass-produced,” said Jeff Schulen, MD, JD, director of the FDA’s Center for Devices and Radiological Health . “By focusing our review on these types of tests and helping to ensure that the available tests are properly supervised, as national testing needs continue to evolve, we can better respond to the pandemic.”

To date, the FDA has authorized more than 420 testing and sample collection devices, which provide a wide range of testing options. Since the beginning of the pandemic, the FDA has adjusted its regulatory methods to meet the public’s testing needs and has been working closely with test developers to adjust to changes in these needs. These efforts help improve testing capabilities and expand the public’s access to rapid testing, including those purchased over the counter (OTC). By early 2022, only the most recent authorization from the FDA may result in the provision of up to 400 million OTC tests to American consumers every month.

Main policy highlights

Today, the U.S. Department of Health and Human Services Withdrawal policy Instructs FDA not to perform pre-market review requirements for laboratory-developed tests (LDT). This action will help ensure that the COVID-19 test is accurate and reliable.

The FDA also updated its testing policies today, including the current LDT provided before or without authorization, as well as policies on the types of tests that the FDA intends to review.

Looking ahead, the FDA generally intends to focus its review on emergency use authorization (EUA) requests for the following types of tests:

• Home and point-of-care (POC) diagnostic tests that can be used with or without a prescription and can be mass-produced;
• Certain laboratory-based high-volume molecular diagnostic tests (and home collection kits for such tests) can expand testing capabilities or accessibility, such as by pooling samples to increase throughput, testing at home, and shipping to the laboratory Laboratory samples, screening asymptomatic individuals or testing multiple different respiratory viruses at the same time;
• Certain high-volume antibody tests based on laboratories and POC can measure the number of antibodies (fully quantitative antibody test) or the number of neutralizing antibodies; and
• Request a test from or supported by a U.S. government stakeholder, such as a rapid diagnosis by the Biomedical Advanced Research and Development Agency or the National Institutes of Health.

Developers of other tests may consider obtaining marketing authorization through traditional device review methods (such as 510(k) notices or De Novo classification).

As discussed in the guidelines republished today, “2019 Coronavirus Disease Testing Policy during Public Health Emergencies (Revised Edition)“The FDA now generally hopes that the newly provided COVID-19 test (including LDT) will obtain EUA or traditional marketing authorization before clinical use, such as the granted De Novo or the approved 510(k). Just like the previous COVID-19 test policy As discussed in, some developers, after verifying the test and providing notification to the FDA, provide their test before the EUA or before the EUA. These policies are designed to expedite the availability of tests, but resulted in some performance before the FDA review Poor testing. Importantly, these policies have never been applied to households or household collection tests. With this in mind, and considering the number of authorized tests available, FDA will terminate these notification policies. Provided for not submitting an EUA request at this time FDA usually wants to submit EUA requests as described in the guidelines. For such tests and notification tests with pending EUA requests, FDA usually intends to review EUA requests. If the test is not subsequently authorized, it is hoped that the developer will receive The test will be discontinued within 15 calendar days after the notification.

In addition, the agency today issued an umbrella EUA for a series of tests using certain molecular diagnostic tests developed in the laboratory. As part of a series of test plans, these tests will be used for regular tests, such as those established in schools, workplaces, or community groups. The Umbrella EUA effectively authorizes certain tests to help increase the chances of obtaining accurate and reliable molecular diagnostic tests.

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