ABSTRACT

COVID-19: FDA Took Steps to Help Make Tests Available, Policy for Future Public Health Emergencies Needed, Report to Congressional Addressees   [open pdf - 957KB]

From the Highlights: "Diagnostic testing for COVID-19 [coronavirus disease 2019] is critical to tracking the virus, informing treatment, and suppressing transmission. However, because COVID-19 is caused by a novel virus, no test existed at the beginning of the pandemic. Typically, medical devices, such as diagnostic tests, must be approved or cleared by FDA [Food and Drug Administration] before they can be offered. However, FDA's EUA [emergency use authorization] authority requires a lower level of evidence than the effectiveness standard normally required for FDA product approval; therefore, it can help tests become available in a shorter amount of time. Test developers submit EUA requests to FDA that include data on a test's performance, and FDA reviews the data to determine whether to grant an EUA. GAO [Government Accountability Office] was asked to review FDA's oversight of tests for COVID-19. This report examines, among other things, 1) the actions FDA took to help make COVID-19 tests available for use, 2) the number of tests FDA authorized and those for which it exercised enforcement discretion, and 3) FDA's monitoring of these tests after they were available for use. GAO reviewed agency documentation, and interviewed FDA and associations that represent test developers. [...] GAO recommends that FDA develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. This policy should include the conditions under which FDA would begin and end the use of such discretion. The Department of Health and Human Services concurred with our recommendation."

Report Number:
GAO-22-104266
Publisher:
Date:
2022-05
Series:
Copyright:
Public Domain
Retrieved From:
Government Accountability Office: http://www.gao.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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