The article provides an overview of the regulatory requirements for monkeypox tests intended to address the public health emergency. In particular, the document describes the current situation with the virus and outlines special extraordinary measures FDA is going to implement in this respect. 

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 monkeypox tests to be used in the context of the public health emergency. The document addressed to laboratories and medical device manufacturers provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, 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 corresponding legislation and has been agreed with the authority in advance. 


Situation Overview

First of all, the authority states that on August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act that there is a public health emergency or significant potential for a public emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. Later in September, it was declared that under these conditions the authorization of emergency use of in vitro diagnostic (IVD) medical devices intended to detect the virus is reasonable and justified. To ensure prompt detection of the virus, the appropriate IVD products should be available on the market. 

The present document describes the approach the authority will apply when reviewing the emergency use authorization (EUA) requests related to the monkeypox diagnostic test, as well as concerning tests developed by laboratories. 

It is important to mention that due to the public health emergency, the present guidance is subject to immediate implementation without prior public consultations which are usually conducted before the new guidance document is introduced. However, the interested parties may still submit their comments and feedback to be considered by the FDA when developing a new version of the guidance. 


As explained by the FDA, monkeypox virus is a zoonotic infection (a virus transmitted to humans from animals), caused by the Orthopoxvirus genus of the Poxviridae family similar to variola virus (the causative agent of smallpox) and can spread among humans. A Public Health Emergency due to the outbreak of the said virus has been announced by the World Health Organization (WHO) in July 2022. There are cases reported in the US as well. Thus, to address the issues related to the outbreak, the authority issues the present guidance describing the framework for tests to be used to identify monkeypox to ensure and expand their availability for healthcare institutions and laboratories. 

Regulatory Background

By the existing legislation, in case of a public health emergency, FDA is intended to introduce special temporary, and extraordinary measures. For instance, in certain cases, the authority may allow the use of medical devices before they will be approved under the general procedure, provided such use is reasonably necessary to address emerging issues. 

As for now, there is an FDA-cleared test that could be used to diagnose, inter alia, the monkeypox virus. Nevertheless, the authority finds it necessary to expand the availability of IVD devices to be used to identify the virus due to the outbreak. The authority will also continuously monitor the situation and implement additional measures when necessary. 

According to the guidance, its scope covers the approach to be applied for expanding testing availability for monkeypox or other non-variola orthopoxviruses developed by medical device manufacturers and laboratories. At the same time, the authority explicitly states that the policy described in the guidance applies to initial testing, while the results of such testing should be confirmed by the virtue of subsequent confirmatory testing. It is also important to mention that the guidance does not apply to medical device reporting (MDR) concerning products supplied and used before or without authorization described in the document. Hence, the parties involved in the development and manufacturing of monkeypox tests should ensure compliance with the applicable requirements for medical device reporting, especially in cases when the use of their devices potentially contributed to or resulted in an adverse event with severe consequences.  

The authority also expects developers of tests that are outside the scope of the policies described [in the guidance document] to submit a EUA request or a premarket submission and receive authorization or clearance before offering or distributing a monkeypox test. 

In summary, the present FDA guidance describes in detail the approach the authority is going to apply concerning monkeypox tests intended to be used in the US during the outbreak. The document outlines the measures the FDA is going to implement to ensure and expand the availability of such tests for healthcare institutions and laboratories under the regulatory framework for a public health emergency. 



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