Immediate release:

Following the recent actions taken by the US Food and Drug Administration to support test development, the FDA moved quickly this week to obtain more tests for screening asymptomatic individuals on the market. Today, the agency has approved over-the-counter drug testing for several over-the-counter drugs for serial screening. In addition to authorized OTC tests, a continuous screening test is authorized for point-of-care (POC) without prescription, and another screening test is authorized for prescription POC. The addition of OTC and POC tests for screening will provide schools, workplaces, communities and other areas with several options for accurate and reliable serial screening tests. These authorizations follow recent actions taken by the FDA to promote the development of OTC and other screening tests.

“Screening tests, especially the over-the-counter tests approved today, are an important part of the country̵

7;s pandemic response-many schools, workplaces, communities and other entities are establishing testing procedures to quickly screen for COVID-19. Yes With the authorization of a number of FDA tests, the public can rest assured that these tests have reached our scientific standards for emergency use authorization. As we have always said, if it is a good test, we will authorize it.” FDA equipment and Jeff Shuren, Director of the Radiological Health Center, MD. “The FDA has taken many steps to support test development throughout the pandemic, including rapid authorization testing, providing test developers with many ways to put their tests on the market with us (if proven to be accurate and reliable), and release implementation Policy. Used for COVID-19 testing. As the pandemic progresses, we work with test developers who want to increase screening requirements.”

In general, the FDA has authorized three tests with a series of screening requirements (multiple tests are routinely performed on asymptomatic individuals). Specific tests authorized this week:

  • Quidel QuickVue at home OTC COVID-19 test-authorized for OTC at home serial screening
  • Abbott BinaxNOW (multiple configurations)
    • Abbott BinaxNOW COVID-19 Antigen Self-Test – Authorized for OTC Serial Screening at Home
    • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test-Authorized to use telemedicine agent for OTC serial screening at home
    • Abbott BinaxNOW COVID-19 Ag 2 Card-PoC continuous screening without a prescription
  • BD Veritor system for rapid detection of SARS-CoV-2-authorized for POC sequence screening with prescription

These tests have previously been authorized by the agency (some use different names) to test those with symptoms of COVID-19, but this week’s action authorizes a series of tests on asymptomatic individuals.

These authorizations follow multiple steps of the agency to simplify the process of conducting a series of tests for test developers who are interested in conducting screening authorizations to increase consumer access to the test, as well as help schools, workplaces, communities and other agencies issued by the FDA. Information on establishing screening procedures.

FDA is an agency of the US Department of Health and Human Services, which protects public health by ensuring the safety, effectiveness and safety of human and veterinary drugs, vaccines and other human biological products, and medical equipment. The agency is also responsible for the safety of national food, cosmetics, dietary supplements, products that emit electronic radiation, and regulation of tobacco products.

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