The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to tests intended to be 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” during the public health emergency. The document provides additional clarifications regarding the regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved. In particular, the document describes in detail the temporary and extraordinary measures introduced to ensure and expand the availability of vitally important devices during the pandemic. At the same time, it is important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying regulations and has been agreed with the authority in advance. The present document constitutes a revised version of the guidance, incorporating the updates based on the new information the authority became aware of during the pandemic.
The scope of the guidance covers, inter alia, the aspects related to modifications to COVID-19 tests already placed on the market and used under the Emergency Use Authorization (EUA) framework – a special pathway that allows making medical devices available to healthcare professionals and patients without undue delays by providing procedures faster than the one set forth under the general rules.
Modifications: Key Points
According to the guidance, numerous policies have been issued by the authority in order to address emerging needs, these policies are also subject to changes, should such changes be reasonably necessary due to the new information becoming available. The policies related to modifications to existing devices are described in detail in the present guidance. At the same time, it is explicitly stated that the approach described herein does not apply to tests intended to be used in a home environment, or the ones that provide at-home specimen collection. The authority provides additional clarifications in order to ensure transparency with respect to the regulatory procedures applied when placing modified medical devices on the market without prior authorization. The authority further recommends that the developers post data about the modified test’s performance characteristics on the developer’s website and that the instructions for use or test protocol and the test reports accurately reflect the modification and prominently disclose that the test has been modified since authorization by FDA and that the modified test has not been reviewed by FDA.
It is also stated that should the authority identify a major issue related to the test subject to modification, and should it appear that the said issue was not duly addressed by the party responsible for a medical device, the authority will expect such a test to be no longer offered. In certain cases, it could be reasonably necessary to initiate a recall and notify all the parties involved about the issue identified, mentioning that test results may not be accurate.
In terms of regulatory policy, the authority describes two situations: when modifications to a COVID-19 test are implemented before or after the issuance of the present guidance.
Modifications Made After Issuance of this Updated Guidance
First of all, the authority emphasizes its intent to prioritize the review of supplemental EUA requests that meet the applicable requirements. All other supplemental requests, falling outside the said scope, will be subject to review in accordance with the general rules and procedures, hence, the respective regulatory requirements should be followed. According to the document, modified COVID-19 tests should be subject to authorization either under the EUA pathway or in accordance with the general requirements for premarket review.
At the same time, it is important to mention that when a high-complexity CLIA-certified laboratory is modifying an authorized COVID-19 molecular diagnostic test, including one for which such laboratory is not the developer of the original, EUA-authorized test, and the modifications do not change the indication for use set forth in the EUA and do not change the analyte-specific reagents, FDA does not intend to object to the implementation of the modification to the diagnostic test without notification to FDA or a new or amended EUA when the laboratory has validated the modification and confirmed that the performance of the modified test is equivalent to the performance of the authorized test, and use of the test is limited to the high-complexity CLIA-certified laboratory in which the modification was made. As further explained by the authority, in situations when the laboratory introducing changes to the test is not the initial developer of the said test, the authority encourages such a laboratory to collaborate with the initial developer – these modifications could be included in a supplemental EUA request, or a request under the general procedure to be submitted by the initial device manufacturer.
Modifications Made Before Issuance of this Updated Guidance
As it was mentioned before, the scope of the guidance also covers the aspects related to modifications to COVID-19 tests introduced before the present guidance document was issued – the ones based on recommendations provided in previous versions of the guidance. In this respect, the authority states that it will not object to the implementation of the modification while FDA conducted its review, except for modifications to add specimen types that have not been previously authorized with another test of the same technology. Consequently, medical device manufacturers are allowed to continue supplying such tests while the authority will perform a review of the respective modifications.
In summary, the present FDA guidance describes the approach to be applied with respect to the modifications to COVID-19 tests allowed for marketing and use in the country. The document provides clarifications regarding the difference in approaches applicable depending on whether the changes took place before or after the issuance of a revised policy by the FDA.
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