The Food and Drug Administration (FDA) issued updated guidance dedicated to tests intended to be used in the context of the outbreak of COVID-19. Due to the importance of the highlighted issues, the guidance is subject to immediate implementation without public consultations prescribed by the general rules. However, the FDA will still accept comments and suggestions from the industry representatives. Such feedback would be taken into consideration when developing the next revision of the guidance.
COVID-Specific Regulatory Background
Due to the fact that the situation with the COVID-19 pandemic changes all the time, the FDA needs to revise guidance documents dedicated to COVID-related factors to be able to address new risks arising. The continuous development and improvement of regulations on COVID-19 tests are also important due to the increasing number of the appropriate tests designed by medical device manufacturers. Nowadays the FDA receives numerous applications for marketing authorization, and thus needs effective regulatory mechanisms in order to ensure and expand the availability of these vitally important diagnostic devices to healthcare institutions and patients. At the same time, the Agency should also maintain the highest level of public health protection providing that only high-quality and effective COVID-19 tests would be allowed for use in the US since the accuracy of results provided by such tests is of the essence. Thus, the FDA continuously improves existing regulations on COVID-19 tests and amends regulatory procedures associated thereto.
The present FDA guidance provides a regulatory approach to COVID-19 tests developed by laboratories or commercial manufacturers. It will remain valid only during the public health emergency declared by the Secretary of Health and Human Services. It is also important to mention that due to its legal nature, the FDA guidance does not set forth any rules or mandatory requirements – the document only provides non-binding recommendations intended to assist medical device manufacturers and other parties involved in operations with medical devices in maintaining compliance with the applicable requirements. Through guidance, the Agency suggests the optimal way, but not requires the industry representatives to follow such recommendations.
As it was mentioned before, the FDA guidance on COVID-19 tests in particular, as well as the whole FDA`s approach to COVID-related regulations, is actually based on the special regulatory regimes introduced in the US due to the COVID-19 outbreak, namely:
- public health emergency, declared by the Secretary of Health and Human Services in January 2020, and
- national emergency declared by the President later in March 2020.
The aforementioned regimes allow the Agency to implement special temporary and extraordinary measures reasonably necessary to address COVID-related issues. One such special approach is the Emergency Use Authorization (EUA).
Under the EUA framework, a medical device that is vitally important in the context of the pandemic could be allowed for marketing and use before being approved by the FDA in accordance with the general procedure. This approach is widely used by the Agency to simplify regulatory procedures associated with placing medical devices on the market and to reduce significantly the time necessary to make such medical devices available to the healthcare institutions and patients.
Nowadays EUA framework is widely used for COVID-19 tests developed by commercial medical device manufacturers. At the same time, the approach applied in the case of tests developed by the authorized laboratories differs substantially. The present guidance on COVID-19 tests covers both frameworks and highlights the most important aspects associated thereto.
It is also important to mention that the FDA has already issued an umbrella EUA for commercial serology tests. The FDA also states that the actual implementation of the aforementioned umbrella EUA demonstrated that the Agency should increase its oversight of commercial serology tests. The Agency is not going to object to the use of serology tests before submitting the EUA application, providing that such tests have been duly validated.
COVID-19 Tests Developed by the Laboratories
According to FDA guidance, the laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing are allowed to develop and use COVID-19 tests. For this purpose, the laboratories may either develop and produce their own components or use ones produced by third party manufacturers.
Under the present FDA policy on COVID-19 tests, the Agency does not intend to object to the use of such test developed by the laboratories, providing that:
- the tests in question have been duly validated, and
- the laboratory that developed the test is already in the process of preparing an EUA submission.
In particular, the laboratory shall duly notify the Agency about successful validation. After this, the laboratory will have 15 business days to prepare and submit an EUA application. As it is stated by the FDA, during this period the laboratory would be allowed to use the COVID-19 test in question.
Regulatory Procedures for Authorized Laboratories
Actually, the whole process includes the following steps:
- Validation. Any tests should be subject to mandatory validation due to the importance of the results they provide.
- Notification. The laboratory should duly notify the FDA about any results achieved. Such notification should include the name of the laboratory, its address, the information about its director and contact person. Upon submission of notification, the laboratory would be included in a special list of laboratories allowed to use self-developed tests. In case if the laboratory would fail to submit an EUA application within 15 business days from the date of the initial notification, such a laboratory would be removed from the aforementioned list and no longer allowed to use the COVID-19 tests in question.
- Reporting of results. According to the guidance, the laboratories shall notify the appropriate health agencies about any results.
- An EUA request. As it was mentioned before, in order to be allowed to use the COVID-19 tests, the laboratory should submit an EUA application within the term specified by the Agency. Upon receipt of the request, the Agency will perform a preliminary review in order to determine the eligibility and compliance with the performance requirements. In case if the issues identified in the course of a preliminary review would be significant, the Agency would require the laboratory to suspend the use of COVID-19 tests and implement the measures necessary to address the issues. Later the laboratory would also have to submit an updated test report confirming that all issues emphasized by the Agency have been successfully corrected. The information about all EUAs would be published on the official website of the Agency.
The FDA also describes the approach to be applied in case of any modifications to the previously issued EUA. In particular, the Agency is not going to object to the use of a modified test, providing that:
- the new specimen type has been previously authorized for another test, and
- the test is validated for the new specimen type.
Thus, any notification, new or amended EUA are not required in case of such modifications. At the same time, the Agency states that in case if the modification is related to the use of a new specimen type that has not been previously authorized for another test of the same technology must be authorized under a new or amended EUA prior to clinical use.
Summarizing the information provided here above, the present FDA guidance describes the approach to be applied for COVID-19 tests developed and manufactured by the laboratories authorized under the CLIA framework. In particular, the guidance describes the particular steps to be taken in order to obtain an EUA to be allowed to use the tests.
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