The new article provides an overview of the revised guidance document and outlines the key points associated thereto.
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 the policy for tests intended to be used in the context of Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” during the public health emergency announced due to its outburst. In particular, the document describes a revised policy the authority applies to such devices. 

It is important to mention 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 and recommendations to be taken into consideration by medical device manufacturers and other parties involved. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with FDA in advance. 

The document highlights the priorities established by the authority with respect to reviewing the applications and applying enforcement policies during the public health emergency. The present document replaces the previous version of the guidance issued earlier in November 2021. It is also important to mention that the policy described in the guidance remains effective only for the term of the public health emergency, so the mechanisms and approaches described therein are extraordinary and temporary in their nature. Furthermore, it is stated that the policy described in the guidance is subject to immediate implementation without prior public consultations being conducted due to the importance of the matters addressed therein. At the same time, the authority encourages industry representatives to provide their feedback and suggestions to be considered later when developing a new version of the guidance.


Regulatory Background 

In accordance with the existing legislation, under certain extraordinary circumstances, healthcare products (including medical devices) could be allowed for marketing and use before the appropriate approval is granted in accordance with the procedures established by the general rules. The said approach could be applied in case it is justified due to the needs related to public health protection. In such cases, the Emergency Use Authorisation (EUA) framework could be applied, ensuring the availability of vitally important medical devices used in the context of a public health emergency. 

According to the guidance, more than 439 tests for COVID-19 were allowed to be used in the US under the EUA framework. Apart from that, two molecular diagnostic COVID-19 tests have been approved under the general pathway. 

The authority additionally emphasizes the importance of proper validation for tests – the results they provide will be used to make clinical decisions regarding the treatment to be applied. In the case of coronavirus disease, this becomes especially important due to the additional measures applied and the resources allocated. 

The policy described in the present guidance is based on the current knowledge and information the authority has collected for the period COVID-19 tests are used. Thus, the authority reserves the right to make changes to the policy, should it be reasonably necessary based on the new information becoming available. 

It is important to mention that the scope of the guidance does not cover the tests intended to be used in a home environment, or the ones based on home specimen collection, but covers all other diagnostic and serology tests for COVID-19. The policy described in the guidance is intended to ensure and expand the availability of the said devices during the public health emergency. 

The authority states that the requirements related to medical device reporting (MDR) are also falling outside the scope of the present guidance. However, the parties responsible for these products are still obliged to comply with the respective obligations. This includes an obligation to notify the authority about any serious incidents and malfunctions of the devices that meet the reporting criteria set forth under the applicable regulatory requirements.

EUA Requests: Overview 

Under the general rule, an Emergency Use Authorisation is issued at the discretion of the authority based on the review of the information provided by an interested party. Such authorization could be issued provided (i) the device meets the applicable regulatory requirements and (ii) the use of the device is vitally important in the context of a public health emergency. The factors the authority will consider when determining the applicability of the EUA are described in detail in the respective guidance document. 

The authority states that the requests related to COVID-19 tests are subject to priority review due to the importance of the issues associated thereto. At the same, it is important to mention that at this stage of the pandemic, FDA intends to prioritize its review of EUA requests and supplemental EUA requests from experienced developers for diagnostic tests that are likely to have a significant public health benefit (e.g., employ innovative technology) or are likely to fulfill an unmet need (e.g., diagnosing infection with a new variant or subvariant). Consequently, the requests that meet the above criteria will be subject to review first, together with the ones supported by a US government stakeholder. 

The authority finds the approach applied to be appropriate to address the current needs. However, the FDA also reserves the right to review the approach and make changes thereto, should it be reasonably necessary. 

Apart from that, since the number of EUA applications that meet the high-priority criteria outlined hereabove is quite limited, the authority encourages medical device manufacturers to follow the standard pathways when possible. 

How Can RegDesk Help?

RegDesk is a holistic Regulatory Information Management System that provides medical device and pharma companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Global expansion has never been this simple.