The U.S. Food and Drug Administration is taking several important actions to support ongoing COVID-19 testing efforts nationwide. These are intended to further increase access to accurate and reliable COVID-19 tests, especially diagnostic tests that can be performed at home or in places such as doctors’ offices, hospitals, emergency care centers, and emergency rooms without having to be sent to a central testing laboratory.
In addition to vaccination efforts, testing remains a cornerstone of the nation’s response to the pandemic and plays a central role in helping Americans return to work, school and other important activities, particularly 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 current COVID-19 testing needs, such as home diagnostic and point-of-care tests that can be produced in large volumes, “he said. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “By focusing our review on these types of testing and helping to ensure that available tests are adequately overseen, we can better respond to the pandemic as the nation’s testing needs continue to evolve.”
To date, the FDA has cleared over 420 tests and specimen collection devices that provide a wide range of testing options. Since the onset 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 change. These efforts have helped to increase testing capacity and expand public access to rapid tests, including those purchased over the counter (OTC). Recent FDA clearances alone could lead to 400 million more OTC tests available monthly to American consumers by early 2022.
Main highlights of the policy
Today, the United States Department of Health and Human Services withdrawn a policy which directed the FDA not to impose pre-market review requirements for laboratory developed tests (LDT). This action will help ensure that COVID-19 tests are accurate and reliable.
The FDA today also updated its testing policies, including LDTs, currently offered before or without authorization, as well as policies regarding the types of tests the FDA intends to focus its review on.
Moving forward, the FDA generally intends to focus its review on Emergency Use Authorization (EUA) applications 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 produced in high volumes;
- Certain high-volume laboratory-based molecular diagnostic tests (and home collection kits for use with such tests) that expand testing capacity or accessibility, such as through clustering of samples to increase productivity, testing of samples collected at home and sent to the laboratory, screening asymptomatic individuals or detecting several different respiratory viruses at the same time;
- Some laboratory-based and POC-based high-volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; Other
- Tests for which the request comes from, or is supported by, a U.S. government interested party, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.
Developers of other tests may consider pursuing marketing authorization through traditional device review paths such as 510 (k) notification or De Novo classification.
As discussed in the guide reissued today, ‘2019 Coronavirus Disease Testing Policy During Public Health Emergency (Revised), “The FDA now generally expects newly offered COVID-19 tests, including LDTs, to have a traditional EUA or marketing authorization such as a De Novo granted or 510 (k) cleared prior to clinical use. As discussed in previous COVID-19 testing policies, some developers offered their tests before or without an EUA after the test was validated and notification to the FDA was provided. testing availability, although they did lead to some poor performing tests being offered prior to FDA review. It is important to point out that the policies never applied to home or home collection testing. With that in mind, and given the number of authorized tests available, the FDA is putting an end to such notification policies in the future. of an EUA application as described in the guide. For such notified tests and tests with pending EUA requests, the FDA generally intends to review the EUA requests and, if the test is not subsequently cleared, expects the developers to stop commercializing the test within 15 calendar days of notification.
In addition, the agency today issued an umbrella EUA for serial testing with some molecular diagnostic tests developed by the laboratories. These tests can be used for testing at regular intervals as part of serial testing programs, such as those established in locations such as schools, workplaces or community groups. The EUA umbrella efficiently authorizes certain tests to help increase access to accurate and reliable molecular diagnostic tests.
The FDA will continue to offer support and expertise to help with the development of accurate and reliable tests and to facilitate greater access to testing for all Americans.