The outbreak of a novel coronavirus, first identified in December in Wuhan, China, has spurred international response and resource mobilization to protect public health and prevent disease spread. Now, with an Emergency Use Authorization issued by FDA for the first diagnostic, a critical milestone has been reached. IVD and medical devices regulatory expert, Haja Sittana El Mubarak, PhD, offers some valuable tips for IVD manufacturers interested in entering the fray.
Global medical device regulators, public health agencies, government leaders, researchers,in vitro diagnostic (IVD) device developers, and many other stakeholders are currently in emergency response mode with the outbreak of a novel coronavirus, originally called 2019-nCoV but officially renamed COVID-19 by WHO in mid-Feb., that can cause severe respiratory illness and even death. The outbreak, first identified from a cluster of pneumonia cases in Wuhan, Hubei Province, China in late December, has spread to approximately 25 countries to date. As of February 6, more than 31,000 cases and 630 deaths from the virus had been reported in China, and more than 250,000 people in the country were under surveillance (these figures climb each day). The China National Medical Products Administration (NMPA) has been implementing emergency approval procedures for diagnostic medical devices to contain the outbreak, and as of January 30 it had reportedly authorized six different brands of diagnostic kits to be deployed to meet the high demand for COVID-19 testing throughout the country.
In the US, the first COVID-19 infection was reported in Washington state on January 21, and 11 confirmed cases have been reported in five states, as of February 5. The US Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), FDA, and the Biomedical Advanced Research and Development Authority (BARDA), along with other public health agencies, have been proactively and jointly preparing for the virus for weeks. “All of the pandemic planning that we have done for influenza is the foundation for our response to this virus,” said Nancy Messonnier, MD, Director of CDC’s National Center for Immunization and Respiratory Diseases, on a February 5 telebriefing.
On January 31, HHS Secretary Alex Azar declared COVID-19 a public health emergency, recognizing the potential threat that the virus poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate, and respond to the outbreak. FDA created a novel coronavirus landing page where it is sharing updates on processes to help product developers understand the Emergency Use Authorization (EUA) and Pre-EUA regulatory pathways. As there are no diagnostic tests cleared by the FDA for the detection of COVID-19, it was determined that an EUA is crucial to ensure timely access to diagnostics. The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.
On February 4, Azar, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act and in response to CDC’s request, declared that circumstances exist to justify emergency use of diagnostics for COVID-19. This official declaration enabled FDA to grant an EUA allowing the immediate, emergency use of the CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The diagnostic, which has not been FDA cleared, is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of COVID-19 from respiratory secretions, such as nasal or oral swabs. The tests began shipping to select, qualified US and international labs on February 5.
FDA also announced that it is providing its highest level of attention to help expedite the development and review of a variety of medical products being developed to diagnose, treat and prevent the spread of this outbreak. It is actively working with other COVID-19 diagnostic developers to help accelerate development programs and EUA requests. As of February 5, 35 have already requested and received the EUA template.
Here, Haja Sittana El Mubarak, PhD, Senior IVD Consultant, Medical Devices at Alexandria, VA-based life sciences regulatory and product development consulting firm Biologics Consulting, provides some valuable tips to Market Pathways readers who may be planning to submit their IVD products via this now-active FDA EUA pathway. Previously, Dr. El Mubarak spent more than 12 years at FDA, primarily in CDRH, as well as serving for five years as the agency’s subject matter expert in Serological and Molecular Diagnostics of Viral Infections.
Reach Out ASAP–Multiple Device Submissions OK
Now that FDA has raised the status of the novel coronavirus to an emergency level, El Mubarak recommends that diagnostic test sponsors interested in potential EUAs for the COVID-19 pathogen contact FDA/CDRH as soon as possible so that their device can be considered, and follow the agency’s guidance closely. Importantly, multiple devices will be considered as long as the EUA is not terminated and there is a need—this has been the case during previous emergencies such as influenza and Zika, she says.
Take Advantage of the Pre-EUA Process
The Pre-EUA process is intended to help streamline the EUA review process during an emergency. El Mubarak recommends that companies interested in submitting their products reach out to FDA to start Pre-EUA/EUA discussions as soon as possible, and be prepared to provide the agency with detailed information about the device design and performance, even if the product is in the early stages of development. FDA scientific and technical subject matter experts (SMEs) will then begin a review of the information and assist in the development of conditions of authorization, fact sheets, and other documentation that helps to facilitate complete EUA requests during the current emergency declaration.
The best part about the Pre-EUA and EUA process is that it brings together SMEs from key agencies, in a collaborative atmosphere, to assist in the development of the documentation to facilitate complete EUA requests, with the overarching goal of protecting public health, says El Mubarak.
IVD developers can submit Pre-EUAs for products that have a current EUA declaration, or products for which there is no current declaration. For both pathways, companies need to submit data and information about the safety, quality, and efficacy of the product, its intended use under a future or—now with COVID-19, a current EUA—and information about the emergency situation. In this current COVID-19 EUA, interested device developers’ first step should be to contact CDRH and request the EUA template applicable to their device.
What’s more, the wealth of information from past Pre-EUA submissions assists the FDA in the development of conditions of authorization, fact sheets, and other valuable resources to developers of new products. “The knowledge base acquired through past Pre-EUA experiences could help tremendously with developing and authorizing products rapidly in response to an emergency situation such as the novel coronavirus outbreak,” she says.
Amendments to Section 564
El Mubarak also recommends that IVD manufacturers note the amendments to Section 564 of the FD&C Act made in recent years by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 and the 2016 21st Century Cure Act. These laws updated key legal authorities to improve and streamline preparedness, and encourage innovation for US public health emergencies involving CBRN agents and emerging infectious disease threats. This includes permitting FDA to waive certain applicable manufacturing requirements to accommodate emergency response needs, and fostering potential use of real-world evidence.
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