The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools.
FDA: Regulatory Background
In order to assist medical device manufacturers in applying for the emergency use authorization for a diagnostic test, the FDA has published a new template to be used as a basis for the applications. The template is intended to be used for diagnostic tests used in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” Such tests are often placed on the market under the emergency use authorization (EUA) – a special regulatory framework introduced by the FDA to ensure and expand the availability of vitally important medical devices during the pandemic, providing those devices that meet certain conditions could be placed on the market without prior FDA approval. In particular, the present template is dedicated to diagnostic tests that should be used outside a laboratory: i.e. at home, at the office, or at school. The FDA also mentions that such devices should be available without a prescription.
According to the FDA’s position, diagnostic tests for home use could play an important role in combating the pandemic, making fast and accurate testing easily accessible by the patients. The document contains recommendations related to the validation of samples for at-home use and over-the-counter diagnostic tests. The document also describes requirements regarding the performance of tests, including such aspects as sensitivity and specificity. It is important to mention that the FDA acknowledges that the actual sensitivity of such tests is significantly lower than for ones intended to be used in accredited laboratories. However, according to their position, in this particular case, the benefits associated with the widely accessible diagnostic tests outweigh the risk associated with the potentially inaccurate results of testing.
Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use
The template has been issued by the FDA in order to provide medical device manufacturers with additional recommendations regarding data and information that need to be included in the pre-EUA or EUA submissions related to the molecular or antigen diagnostic tests intended to be used outside of accredited laboratories. The Agency explicitly states that the template should not be used for home collection kits.
The FDA template refers to the rules and requirements set forth in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, the main document regulating the sphere of COVID-19 tests. In accordance with the aforementioned FDA guidance, the validation studies should include:
- Limit of Detection,
- Clinical Evaluation,
- Inclusivity,
- Cross-reactivity,
- Usability, and
- Flex Studies.
In particular, the present FDA template is intended to assist medical device manufacturers in providing data and information related to the aforementioned studies in a format deemed acceptable by the FDA. However, the FDA also mentions that alternative approaches could be discussed and used. The template itself contains non-binding recommendations to be considered by the medical device manufacturers when filing an EUA submission. The document also contains some references to the mandatory rules set forth by the applicable regulations. This is evident in EUA-specific requirements as the document refers to the appropriate FDA guidance Emergency Use Authorization of Medical Products and Related Authorities.
Template on At-Home Use and OTC Tests: Key Points
Besides the aforementioned aspects, the FDA template and informative description contained therein contains the following key points to be considered by medical device manufacturers or their authorized representatives applying for the emergency use authorization:
- the emergency use authorization remains valid only during the term of public health emergency associated with the COVID-19 outbreak,
- the present template represents the current thinking of the Agency regarding the matter, and it could be subject to certain changes or amendments in case they would be reasonably necessary,
- the template covers only the diagnostic tests based on the use of respiratory specimens or saliva, while non-respiratory specimens actually fall outside of the scope of the document and need to be discussed with the FDA additionally.
- those who get positive test results should contact their physician and seek treatment; at the same time, those who received a negative test result but still have the symptoms usually associated with the COVID-19 should also contact their physician.
In accordance with the template developed by the FDA, the application for the EUA should contain the following information and data:
- Indication of the purpose of the submission, including the claimed specimen types and the way the tests in question should be used (e.g. at-home use).
- Depending on the type of the test subject to review, the application should contain the details regarding the targeted gene(s) or targeted antigen(s).
- Information about the applicant, including its official name, place of business (address), and contact information.
- Proprietary and established names.
- Regulatory information, including the FDA clearance status (an indication of whether the device has been approved or waived).
- Indication of the product code (which is QJR for molecular diagnostic tests and QKP for antigen diagnostic tests.
- Information about the proposed intended use, including a detailed description of the diagnostic COVID-19 tests, covering such points as the technology the test is based on (e.g. real-time RT-PCR), details regarding the suitable specimen types and special requirements and conditions.
- Special indications, such as «For Emergency Use Authorization only» or «For prescription use only» or «For prescription use and over-the-counter use», «For in vitro diagnostic use only».
- Special instrument requirements describing any additional instruments to be used.
According to the template, when applying for the emergency use authorization for molecular or antigen diagnostic COVID-19 tests, the manufacturer or its authorized representative should provide a Device Description and Test Principle. The FDA reserves the right to request additional information that would be reasonably necessary to assess the case.
Another important point covered by the FDA template is related to internal control. The FDA emphasizes that in order to reduce the impact of the relatively lower accuracy of the results obtained when using diagnostic COVID-19 tests for at-home (non-laboratory) use, manufacturers should duly implement special internal control mechanisms that allow users to ensure that the specimens have been properly collected and the analysis could be performed. Such internal control measures could be implemented in the form of special technical elements that are the integral parts of the design of the medical device or in the form of video observation carried out by the healthcare professional.
Summarizing the information provided hereabove, the template for pre-EUA/EUA submissions related to the at-home use and over-the-counter diagnostic COVID-19 tests covers the most important aspects to be considered by the medical device manufacturer or its authorized representative when applying for the authorization of the COVID-19 molecular or antigen assay under the EUA framework.
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