The Food and Drug Administration (FDA) is working to expand the capacity to provide COVID-19 testing in the United States. In the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency published March 16, 2020, the FDA updated its policies to achieve more rapid testing capacity for the novel coronavirus. The Policy specifically addresses options for laboratories and commercial manufacturers to help accelerate the use of tests developed in order to achieve more widespread testing capacity in the United States.
This policy was developed in response to a determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19. It allows for the development of tests without first submitting an Emergency Use Authorization (EUA), which allow for unapproved medical products, or unapproved uses of approved medical products in certain emergency circumstances, in order to diagnose, treat or prevent life-threatening conditions, when certain criteria are met.
The FDA also published FAQs that provide important information for manufacturers, labs and others interested in offering COVID-19 testing, and are discussed below.
It is also holding a Virtual Town Hall for on the Coronavirus Diagnostic Tests guidance on Wednesday, March 25, 2020 from 3 pm to 4 pm ET.
Laboratories Certified Under CLIA That Meet the CLIA Regulatory Requirements to Perform High Complexity Testing Using Validated Tests Prior to EUA Submission
On Feb. 29, 2020, the FDA issued its initial policy on Emergency Use Authorizations in response to COVID-19. This policy was only applicable to laboratories certified to perform high-complexity testing consistent with requirements under CLIA. The March 16 Policy revises this and provides that the FDA does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA, under certain circumstances. First, all clinical tests must be validated prior to use. The FDA has provided recommendations regarding minimum testing that should be performed to ensure analytical and clinical validity in the Policy, including specific recommendations for molecular diagnostics, antigen detection diagnostics and serological diagnostics. Second, the laboratories must provide notification to the FDA, which includes the clinical validation information. Finally, within 15 business days of submitting the initial notification, an EUA must be submitted. While the manufacturer is preparing its EUA, the manufacturer must provide instructions for use of the test and post data about the test’s performance characteristics on the manufacturer’s website.
State Authorization of Laboratories Certified Under CLIA That Meet the CLIA Regulatory Requirements to Perform High Complexity Testing
The Policy states that a State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 may do so under authority of its own State law, and under a process that it establishes, without any engagement with the FDA. The FDA does not intend to object to the use of such tests, and does not require that test validation be submitted to the FDA, nor does it require that an EUA be submitted to the FDA. In the FAQs, the FDA states that New York, Maryland, Nevada and Washington State have notified FDA that they choose to use this flexibility to expedite COVID-19 testing. As stated in the guidance, the FDA will not be reviewing the process adopted by the State or territory.
Commercial Manufacturer Development and Distribution of Tests
The Policy also provides two options for commercial manufacturers developing COVID-19 testing for clinical laboratories or for point-of-care settings. First, if the test is a serological test which measures the amount of antibodies or proteins present in the blood when the body is responding to a specific infection) the FDA has taken the position that it will not object to the distribution, so long as: 1) the test has been validated, 2) notification has been provided to the FDA, and 3) disclaimer language is included on the test noting that the test has not been reviewed by the FDA. This option exists for serological tests only and submission of an EUA is not required. The FDA lists in its FAQs four commercial manufacturers who have notified FDA that they have validated and are distributing test kits as set forth in Section IV.D of the Policy. The FDA has not yet reviewed the validation of these tests or issued EUAs for these manufacturers' tests.
The second option for commercial distributors are for any other type of test (i.e. antigen detection, molecular, etc.). Commercial manufacturers must provide assay validation with their notification to the FDA, then submit a complete EUA within 15 business days. While awaiting FDA determination on the EUA request, FDA recommends that manufacturers make publicly available on their website the instructions for use, including a summary of assay performance. If the FDA is not able to authorize an EUA, FDA intends to notify the manufacturer and the manufacturer must suspend distribution and conduct a recall of the test. Twelve commercial manufacturers and laboratories have notified FDA that they have validated and are offering serology tests as set forth in Section IV.C of the Policy. The FDA has not reviewed the validation of these tests.
Notes on the FAQs
1. At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19, but is working with test developers in this space.
2. Many commercial and health care system/academic laboratories (39 are listed in the FDA FAQs) have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in Section IV.A of the Policy. The FDA has not yet reviewed the laboratory's validation of tests offered under this policy or issued EUAs for these laboratories' tests. The FDA notes that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an EUA authorized test. In addition, under the Policy, States may choose to authorize COVID-19 testing by laboratories within their State.
3. The FAQs also discuss whether clinical labs, even those certified to perform high complexity testing under CLIA, need an EUA if they purchase a CDC qualified lot of SARS CoV-2 test reagents and wish to develop their own protocols, and state that laboratories that wish to develop their own protocol should refer to the streamlined EUA policy outlined in the Policy. If a clinical lab wishes to develop a SARS-CoV-2 test and needs to make its own primers/probes or order individual components, the FDA encourages those labs to consider the validation recommendations in the Policy as they seek to validate their tests. Any alternate approach should be discussed with the FDA early, through the pre-EUA program.
Once a test is validated and clinical testing is ready to begin, labs should notify the FDA at CDRH-EUA-Templates@fda.hhs.gov, confirm the first five positive and the first five negative samples with an EUA-authorized test and include in the test report a statement that the FDA review of the validation is pending. The FDA does not intend to object to the use of validated tests for specimen testing for 15 days after validation while the laboratory is preparing an EUA request.
The FAQs instruct that test developers and labs who have questions about the EUA process or spot shortages of testing supplies should contact the toll-free line 24 hours a day: 1-888-INFO-FDA, choose option *.
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