As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to accelerate the availability of diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency. The first such EUA was recently authorized for an unapproved point-of-care test for COVID-19, which promises results within hours, rather than days.
In conjunction with revised, immediately in effect guidance, here are several key points laboratories and manufacturers should consider when developing tests and obtaining approvals for their production and use under an EUA.
- The EUA Process Requires Express FDA Review and Approval. The Federal Food, Drug, and Cosmetic Act provides FDA with narrow EUA authority to allow unapproved medical products or unapproved uses of approved medical products in emergency situations. Included in the scope of EUA issuances are products used to diagnose, treat or prevent serious or life-threatening diseases or conditions when there are no adequate, approved or available alternatives. To obtain an EUA from FDA for an unapproved product or use, such as the point-of-care test for COVID-19, the lab or manufacturer generally must submit an EUA request. FDA has provided templates on its website for EUA requests for both laboratories and manufacturers. Additionally, FDA provided a FAQ page addressing questions about the EUA process and spot shortages of testing supplies, as well as a 24-hour hotline to answer questions (1-888-INFO-FDA, option*).
- FDA Guidance Limits Participants. FDA provided further clarification related to COVID-19 EUA submissions in guidance, but limited participants to certain laboratories and manufacturers. FDA also stated that it does not intend to object to states’ requests to authorize laboratories or manufacturers within their borders or territories to develop their own COVID-19 tests and perform specimen testing.
Laboratories – The guidance applies to laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) that meet the CLIA regulatory requirements to perform high-complexity testing. Such laboratories may seek to develop diagnostic tests for COVID-19 and pursue authorization to perform the tests through the EUA process.
Manufacturers – The guidance also applies to commercial manufacturers that seek to develop diagnostic test kits and distribute them to laboratories and healthcare professionals. FDA indicated that it does not intend to object to a commercial manufacturer’s distribution of COVID-19 test kits for specimen testing for a reasonable period of time (about 15 days) after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request. During this time, manufacturers must provide instructions for use of the test and post data about the test’s performance characteristics on the manufacturer’s website.
- FDA Guidance Requires Specific Standards for Efficacy Validations. All tests must be validated as effective prior to use. FDA has provided recommendations within the guidance that manufacturers and laboratories should follow to ensure their products accurately detect COVID-19. Section V of the guidance document provides the specific diagnostic tests and standards to appropriately validate (for purposes of EUA request submission) molecular diagnostics, antigen detection diagnostics and serological diagnostics testing.
- FDA Will Continue to Enforce Against Fraudulent Tests. It should be noted that FDA’s guidance does not apply to at-home testing and FDA has not approved any at-home COVID-19 tests. FDA has warned consumers against these products and continues to “aggressively” monitor the market for fraudulent marketing of such at-home kits. As of March 9, 2020, FDA and the Federal Trade Commission have issued at least seven warning letters to companies selling these unapproved COVID-19 treatment products, which may subject the companies to additional legal action, including seizure of goods or injunctions. In addition to addressing fraudulent testing, FDA has warned consumers against the use of fraudulent vaccines or drugs to treat or prevent COVID-19 and will continue to monitor the market and enforce against fraudulent devices and drugs.
Laboratories and manufacturers wishing to provide COVID-19 tests should review FDA’s guidance related to its EUA for such products. Please contact the authors if you have questions regarding this process or FDA’s guidance related to the COVID-19 response.
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