The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published an updated version of the guidance document dedicated to tests intended to be used in the context of the Coronavirus Disease 2019 (COVID-19). The document describes the respective policy followed by the authority, introducing temporary and extraordinary measures intended to expand and ensure the uninterrupted availability of the said tests on the US market.
It is worth mentioning that guidance documents issued by the FDA are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation and has been agreed with the authority in advance.
High-Complexity CLIA-Certified Laboratories: State Authorization
According to the guidance, its previous version contained additional clarifications regarding the regulatory approach the authority applies with respect to laboratories allowed to develop their own tests and use them during the public health emergency. The FDA mentions that such authorization was allowed even without submitting an Emergency Use Authorization (EUA) request. In accordance with the said policy, a State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 would do so under the authority of its own State law, and under a process that it established, and FDA did not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation was not submitted to FDA and the laboratory did not submit an EUA request to FDA, and where instead the State or territory took responsibility for COVID-19 testing by laboratories in its State during the COVID-19 outbreak. The authority further explains that the approach described hereabove applies to in vitro diagnostic (IVD) devices that are initially designed, developed, and used within a single high-complexity, CLIA-certified laboratory. At the same time, tests intended for home use are falling outside the scope of the present policy.
As explained by the authority, under the previous version of the policy, the States or territories were obliged to notify the FDA about all such authorizations granted, even though the respective processes related to authorization were not subject to FDA’s review or approval. However, the authority expected the States and territories to ensure all the tests are duly validated before being used. Furthermore, the authority encouraged the laboratories to commence clinical testing in order to validate the actual performance of COVID-19 tests they develop and to ensure the accuracy and reliability of the results such tests provide.
However, according to the changes introduced in November 2021, it was decided not to apply the said policy to any additional States or territories. Hence, it was prescribed that the States and territories are entitled to authorize laboratories to design, develop and use COVID-19 tests without notifying the FDA while being responsible for such authorizations. As it was mentioned before, this approach will not be applicable with respect to tests intended to be used in the home environment or with home specimen collection. At the same time, the authority additionally emphasizes the importance of ensuring the laboratories involved are fully aware of the reporting obligations prescribing that test results should be communicated to the respective healthcare agencies.
Tests Distribution During FDA Review
The scope of the guidance also covers the aspects related to the distribution and offering of COVID-19 tests during a review carried out by the authority. According to the previous versions of the guidance, the authority explicitly confirmed it was not intended to object to the distribution of certain tests before the formal authorization will be granted. The said approach has been reviewed by the authority, so the current version of the respective policy states the following:
- The authority will not object to the distribution and use of tests included in the notification list published on the authority’s website, as well as the Laboratory developed tests (LDTs) initially offered before November 2021, for which the appropriate EUA requests have been duly submitted. Should the authority decide to change its approach with respect to particular tests falling within the scope described hereabove, the responsible parties will be notified accordingly. In particular, the authority is entitled to request the distribution or use within 15 calendar days by issuing the appropriate notice. Furthermore, in case of serious issues identified, the authority will expect the entity responsible for the test in question to take all necessary steps to address such issues, including initiating a recall or missing a notification informing all the parties involved about potentially incorrect test results.
- It should be clearly indicated in the test results that the device used hasn’t been reviewed by the authority, while any references to FDA’s approval or authorization will be considered false and misleading. The authority also mentions that developers should make publicly available on their website the instructions for the use for the test and data about the test’s performance characteristics, including a summary of assay performance. Apart from this, the appropriate statements should be included in the instructions for use (IFUs), notifying potential users about the possibility of getting an incorrect result.
In summary, the present FDA guidance describes the approach the authority will apply with respect to COVID-19 tests designed, developed, and used by CLIA-certified laboratories under the authorization granted by the respective State or territory. The document also provides clarifications on the regulatory status of tests currently being under the authority’s review and outlines specific conditions to be fulfilled in order for such tests to be allowed for distribution and use before formal approval will be granted by the FDA.
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