Introduction to the post-public health emergency landscape
As we move into the post-public health emergency landscape with the expiration of the national emergency concerning the coronavirus disease 2019 (COVID-19) pandemic on May 11, 20231, it is essential to understand how the healthcare industry has adapted and evolved to address the unique challenges posed by the COVID-19 pandemic. The situation has forced healthcare professionals and policymakers to rethink their strategies and implement new measures to ensure the safety and well-being of people. In this article, we will discuss the role of Emergency Use Authorization (EUA) in facilitating rapid diagnostic testing, specifically focusing on the Visby Respiratory Health Test and how it remains unaffected in the new landscape.
In the following sections, we will delve into the intricacies of EUA, the role of the FDA in public health emergencies, and the Visby Respiratory Health Test.
The role of FDA and Emergency Use Authorization (EUA)
The FDA plays a critical role in protecting public health during emergencies, such as pandemics, natural disasters, and bioterrorism events. The agency is responsible for regulating medical products, including drugs, medical devices, and biologics, to ensure their safety, efficacy, and quality. When it is determined that “there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents2,” FDA may enact the use of Emergency Use Authorizations.
Emergency Use Authorization (EUA) is a regulatory mechanism that allows the US Food and Drug Administration (FDA) to authorize the use of unapproved medical products or unapproved uses of approved medical products during a public health emergency. This mechanism is designed to provide healthcare providers with access to critical medical products when there is no adequate, approved, and available alternative. The FDA determination of a public health emergency (or significant potential of one) is separate from and does not depend on the national emergency concerning the COVID-19 pandemic.
In the context of in vitro diagnostic tests, the EUA declaration3 has played a significant role in expediting the development and availability of COVID-19 tests, allowing healthcare providers to diagnose and manage the disease more effectively. In March 2023, the Secretary of Health and Human Services confirmed that the EUA declarations are still in effect due to the fact that circumstances still exist that COVID-19 has a “significant potential for a public health emergency”4. As such, EUA’s issued for in vitro diagnostics by FDA remain in effect despite the May 11, 2023 expiration of the national emergency.
Visby Medical Respiratory Health Test
The Visby Medical Respiratory Health Test is a portable, single-use PCR diagnostic test designed to detect multiple respiratory pathogens, including SARS-CoV-2, the virus that causes COVID-19. This point-of-care test provides rapid and accurate results, assisting healthcare providers to diagnose respiratory infections and make informed treatment decisions during the patient visit. The Visby Medical Respiratory Health Test combines the accuracy of PCR testing with the convenience of point-of-care testing. This unique combination enables healthcare providers to deliver rapid and accurate test results to aid in the diagnoses of respiratory infections, including COVID-19, supporting more effective patient management, and helping to alleviate the strain on healthcare systems.
The FDA granted Emergency Use Authorization (EUA) for the Visby Respiratory Health Test in response to the COVID-19 pandemic. The EUA declaration enabled the FDA to authorize the use of unapproved products, providing healthcare providers with access to critical medical products during a public health emergency. The Visby Medical Respiratory Health Test authorization allows the test to be used in CLIA certified laboratories that meet the requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Despite the evolving public health emergency landscape, the Visby Medical Respiratory Health Test’s EUA status remains unaffected, and Visby Medical continues to manufacture and sell the respiratory health test under the EUA. The test provides a valuable diagnostic tool for healthcare providers, offering rapid and accurate detection of multiple respiratory pathogens, including SARS-CoV-2, which is still a significant potential threat to public health. The test’s EUA status allows it to be used in certified laboratories and other settings, providing healthcare providers with a reliable and effective diagnostic tool.
In a post-public health emergency world, healthcare providers will need to be better prepared to respond to emerging threats, including new infectious diseases. Rapid, accurate, and innovative diagnostic tools like the Visby Respiratory Health Test will be essential in controlling the spread of diseases and minimizing their impact on public health.
- Continuation of the National Emergency concerning the coronavirus disease 2019: https://www.federalregister.gov/documents/2023/02/14/2023-03218/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic
- FDA may enact the use of Emergency Use Authorizations: https://www.govinfo.gov/content/pkg/USCODE-2021-title21/pdf/USCODE-2021-title21-chap9-subchapV-partE-sec360bbb-3.pdf
- EUA declaration: https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency
- Significant potential for a public health emergency: https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration
Visby Respiratory Health Test
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.