The FDA is taking a number of important steps to support ongoing nationwide COVID-19 testing efforts. These actions aim to further expand access to accurate and reliable tests for COVID-19, especially diagnostic tests that can be performed at home or in locations such as doctors’ offices, hospitals, emergency centers and emergency departments, without the need to be sent to a central laboratory. … for testing.
“Beyond vaccination efforts, testing remains a cornerstone of the national response to the pandemic and is central to helping Americans get back 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 country’s current testing needs for COVID-19, 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 review on these types of tests and helping ensure proper oversight of the available tests, we can better respond to the pandemic as the country’s testing needs continue to evolve.”
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To date, the FDA has authorized over 420 tests and sample collection devices that provide a wide range of testing options. Since the outbreak of the pandemic, the FDA has adapted its regulatory approach to meet the testing needs of the population and is working closely with test developers to adapt to the changes. These efforts have helped increase testing opportunities and increase public access to rapid tests, including over-the-counter (OTC) tests. Recent FDA approvals alone could result in up to 400 million additional over-the-counter tests available monthly to American consumers by early 2022.
Key policy points
Today the U.S. Department of Health and Human Services withdrew policy this instructed the FDA not to enforce laboratory-designed test (LDT) pre-market testing requirements. This action will help ensure the accuracy and reliability of COVID-19 tests.
The FDA today also updated its policy on tests, including LDTs that are currently offered with or without authorization, as well as policies on the types of tests the FDA intends to focus on.
Moving forward, the FDA usually 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 for prescription or non-prescription use and which can be produced in high volumes;
- Certain bulk laboratory molecular diagnostic tests (and home collection kits for use with such tests) that enhance the capabilities or availability of testing, for example, by pooling samples to increase throughput, testing samples collected at home and sent to the laboratory, screening asymptomatic people or the simultaneous detection of several different respiratory viruses;
- Defined high-volume laboratory and POC antibody tests, which can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and
- Tests requested or supported by a US government stakeholder, such as the Biomedical Advanced Research and Development Agency or the National Institutes of Health’s Rapid Diagnosis.
Developers of other tests may consider obtaining marketing authorization using traditional device verification methods such as 510 (k) notice or De Novo classification.
As discussed in the manual being republished today:2019 Coronavirus Disease Testing Policy During a Public Health Emergency (Revised)The FDA now generally expects recently proposed COVID-19 tests, including LDT, to have EUA or traditional marketing authorization such as De Novo granted or 510 (k) approved prior to clinical use. As discussed in previous COVID-19 testing guidelines, some developers offered their tests before or without the EUA after the test was approved and a notification was sent to the FDA. These regulations were intended to speed up the availability of tests, although they have led to the proposal of some ineffective tests prior to FDA approval. It is important to note that these rules have never been applied to home tests or home gatherings. With this in mind and given the number of authorized tests available, the FDA is discontinuing these notification policies in the future. For tests currently offered without an EUA request, the FDA will generally await an EUA request as described in the guidance. For such tests and notified tests with pending EUA requests, the FDA generally intends to consider EUA requests and, if the test is not subsequently approved, expects developers to stop selling the test within 15 calendar days of notification.
In addition, the agency today released the EUA batch testing umbrella with specific molecular diagnostic tests developed by laboratories. These tests could be used for testing at regular intervals as part of serial testing programs such as those set up in places such as schools, workplaces, or community groups. The umbrella EUA effectively permits certain tests to help expand 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 test access for all Americans.