FDA UPDATE Coronavirus (COVID-19) Update: FDA t

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Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs.

For Immediate Release:
March 16, 2021
Statement From:
Director - CDRH Offices: Office of the Center Director
Dr. Jeffrey E. Shuren MD, JD

Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions, such as whether an individual should participate in an activity, based on the test results.

Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs. Our actions complement those taken by the Centers for Disease Control and Prevention (CDC) and are not intended to replace CDC’s testing or other public health guidance.

First, the FDA issued a new supplemental template for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per week, along with other mitigation measures, such as masking and social distancing, to reduce disease transmission. This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This includes tests conducted in any location, including in a laboratory, at the point-of-care (POC), or even places such as a person’s home or certain non-traditional sites such as offices, sporting venues, airports, schools, etc.

We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing.

As part of this new template for test developers, the agency provided recommendations aimed to streamline the authorization of screening tests with serial testing. The recommendations apply to test developers who seek an EUA from the FDA for certain screening tests prior to conducting certain performance evaluations with asymptomatic individuals. For example, in certain circumstances, a POC test or an at-home test could be authorized for over-the-counter (OTC) use without the need for validating its use in asymptomatic individuals prior to authorization. The FDA believes that evidence of a test’s strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals.

Additionally, today the FDA issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program. The fact sheet will help schools, workplaces, communities and other locations as they are selecting a test for screening and help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals.

This information we’re providing will be helpful to groups as they set up testing programs. We believe these combined efforts will further expand the availability of tests authorized for screening asymptomatic individuals, including OTC use, help bolster existing and new testing programs and increase consumer access to testing.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

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