Streamlining COVID-19 Test Development with FDA Diagnosis Templates

The expiration of the COVID-19 Public Health Emergency (PHE) on May 11, 2023, marked a significant shift in the regulatory landscape for medical devices, particularly diagnostic tests. While the PHE’s end has sunset certain enforcement policy guidances, the U.S. Food and Drug Administration (FDA) continues to uphold Emergency Use Authorizations (EUAs) for COVID-19 related devices. For manufacturers navigating this transition, understanding and utilizing Diagnosis Templates for EUA submissions is crucial for continued compliance and market access.

The FDA has proactively provided resources to assist manufacturers in adapting to the post-PHE environment. Crucially, existing EUAs for COVID-19 diagnostic tests remain in effect. However, the FDA strongly encourages manufacturers to transition towards traditional premarket review pathways to ensure the long-term availability of these critical tests. To facilitate this transition, the FDA has issued comprehensive guidance documents, including the “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)”. This guidance outlines the necessary steps for manufacturers to develop transition implementation plans and submit marketing submissions for their devices.

Alt: FDA webpage showcasing guidance documents related to the transition plan for medical devices during the COVID-19 public health emergency.

In vitro diagnostic (IVD) devices, which encompass a wide range of COVID-19 tests, play a vital role in detecting and managing the virus. These tests are performed on samples from the human body and are essential for diagnosis, monitoring, and informing treatment strategies. The FDA categorizes SARS-CoV-2 and COVID-19 related IVDs into several types, including:

• Diagnostic Tests: These tests, encompassing molecular (NAATs) and antigen tests, directly detect the SARS-CoV-2 virus to diagnose active infections.
• Serology/Antibody Tests: These tests identify past infections by detecting antibodies to the virus. They are not suitable for diagnosing current infections but are valuable for epidemiological studies and understanding immune response.
• Tests for COVID-19 Patient Management: Beyond diagnosis, certain tests are authorized to monitor COVID-19 patients, such as those detecting biomarkers related to inflammation, aiding in clinical decision-making.

Since the initial declaration of emergency in February 2020, the FDA has granted numerous EUAs for COVID-19 tests. These EUA-authorized tests remain permissible for use as long as they are within their expiry dates and the EUA is not revoked. The FDA is actively working with test developers to transition their products from EUA to traditional marketing authorization, ensuring continued access to reliable diagnostic tools.

Utilizing Diagnosis Templates for EUA Submissions

To streamline the EUA submission process, the FDA has provided specific diagnosis templates. These templates are designed to guide test developers in preparing comprehensive and well-structured EUA requests. These templates are available for various types of COVID-19 tests, categorized as:

• Diagnostic Templates (Molecular and Antigen)
• Serology/Antibody Templates

These diagnosis template resources are integral to the FDA’s “Policy for Coronavirus Disease-2019 Tests (Revised)”. They represent the FDA’s current recommendations on the data and information required for a successful EUA submission. By using these templates, developers can ensure their submissions align with FDA expectations, potentially expediting the review and authorization process. The FDA emphasizes that these templates are living documents and will be updated as understanding of COVID-19 evolves and experience with the EUA process grows.

Alt: FDA website section highlighting the availability of EUA submission templates as part of their COVID-19 test policy.

Developers considering alternative testing methodologies are encouraged to engage with the FDA early in the process. Seeking feedback and recommendations from the FDA can help navigate the EUA pathway effectively. For technical discussions or clarifications regarding diagnosis templates and alternative approaches, developers can contact the FDA at [email protected]. General inquiries about COVID-19 tests can be directed to [email protected].

For developers seeking to leverage performance data from a previously EUA-authorized device, obtaining a “right of reference” is necessary. Notably, the Centers for Disease Control and Prevention (CDC) has granted a right of reference to their EUA performance data (EUA200001), which can be beneficial for developers seeking FDA EUA for similar diagnostic devices. Further information and answers to frequently asked questions are available on the FDA’s “FAQs on Testing for SARS-CoV-2” page.

In conclusion, while the public health emergency has ended, the need for accurate and reliable COVID-19 diagnostic tests remains. The FDA’s provision of EUA diagnosis templates and ongoing guidance demonstrates their commitment to supporting test developers in navigating the regulatory landscape. By utilizing these resources and engaging in open communication with the FDA, manufacturers can effectively contribute to public health through the continued availability of essential diagnostic tools.