The guidance describes a number of important policies concerning the circumstances under which certain entities may perform laboratory testing or distribute test kits on a more expedient timeline than would normally be permitted.
On March 16, 2020, the U.S. Food & Drug Administration (FDA) issued new guidance aimed at accelerating the availability of COVID-19 diagnostic tests developed by laboratories and commercial manufacturers. The guidance, which took immediate effect upon release, contains recommendations for clinical laboratories and commercial manufacturers regarding development of diagnostic tests for COVID-19 during the current public health emergency.
As the guidance recognizes, there is currently an outbreak of a respiratory virus named SARS-CoV-2, which causes a disease named Coronavirus Disease 2019 (hence COVID-19). The guidance also acknowledges that COVID-19 poses a high potential public health threat “both globally and to the United States.” Effectively responding to the COVID-19 outbreak requires “rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts.”
To that end, the guidance describes a number of important policies concerning the circumstances under which certain entities may perform laboratory testing or distribute test kits on a more expedient timeline than would normally be permitted under FDA regulations and policies.
Post-Validation, Pre-EUA Submission Testing by CLIA-Certified Laboratories
The first policy described in the guidance applies to labs certified under the Clinical Laboratory Improvement Amendments (CLIA). These labs meet CLIA regulatory requirements to perform high-complexity testing and seek to develop and perform diagnostic tests to detect the SARS-CoV-2 virus and pursue emergency use authorization (EUA) from FDA for those tests.
For a period of 15 days after the tests have been validated, and while the labs are preparing their EUA requests, the tests may be used for specimen testing without FDA objection. (This policy is conditioned on a number of requirements contained in the guidance, which also lists a series of recommendations to the laboratories covered by the policy.)
Testing by State-Authorized Laboratories
The second policy applies to states or territories that have chosen to authorize laboratories within their jurisdiction to develop and perform COVID-19 tests, and where notification of SARS-CoV-2 test validation is not submitted to FDA and the lab does not submit an EUA request. Under such circumstances, assuming a given state takes responsibility for COVID-19 testing by the laboratories in its jurisdiction during the outbreak, FDA does not intend to object to COVID-19 testing by labs in that state. (As with the policy discussed above, this one is also conditioned on a number of requirements, and is presented along with requests and recommendations, including that states choosing “to use this flexibility to expedite COVID-19 testing” notify FDA of their decision to do so.)
Distribution of Test Kits by Commercial Manufacturers
The third policy concerns the extent to which commercial manufacturers may distribute SARS-CoV-2 diagnostic test kits to clinical labs or healthcare workers before submission of EUA requests. For these types of test kits, FDA states in the guidance that it does not intend to object to a commercial manufacturer’s development and distribution of such test kits for specimen testing during a period of 15 days after validation, during which time the manufacturer prepares its EUA request. This is assuming that the manufacturer provides use instructions with the test kits and posts data on the test’s performance characteristics on its website. Importantly, this policy does not apply to at-home testing. (As with the policies discussed above, this one is also conditioned on a number of requirements, and is also presented along with requests and recommendations.)
Development, Distribution and Use of Serology Tests Without an EUA
FDA also states in the guidance that it does not intend to object to commercial manufacturers’ development and distribution of, and laboratories’ use of, serology tests to identify antibodies to SARS-CoV-2. However, the tests must be validated, FDA notified and the test reports must contain certain information specified in the guidance (including that the test has not been reviewed by FDA, etc.).
In addition to the policies referenced above, the guidance contains a number of additional recommendations, including how to conduct validation studies for certain SARS-CoV-2 diagnostics and when to conduct additional studies.
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