The FDA’s Stephen M. Hahn, MD, Commissioner of Food and Drugs, details how the agency’s CDRH has ramped up its medical device regulatory and authorization efforts in response to the COVID-19 pandemic:
If you want to know the U.S. FDA’s impact on COVID-19, look no further than the numbers. In a few short months, the agency’s Center for Devices and Radiological Health’s (CDRH) response to the pandemic has been unprecedented in terms of volume, speed, and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment, and extensive engagement with stakeholders. Additionally, over 50 percent of CDRH employees have dedicated an incredible number of hours to the COVID-19 response, in addition to performing their existing responsibilities at the FDA.
As we grapple with COVID-19, the echoes of the 1918 pandemic ring loud and clear. Although that virus infected more than 500 million people – or one-third of the world’s population—and killed 675,000 Americans, modern day travel has made the potential of this pandemic very concerning. One important difference today is the availability of critical medical devices, including diagnostic tests, more effective personal protective equipment (PPE), and better ventilators and respiratory assist devices. And because these devices have been available – coupled with the heroic efforts of our nation’s health care workers – the death toll, while still too high, is far below what we experienced a century ago.
As we reflect on the efforts and lessons learned in our response to the pandemic, I must acknowledge the essential role CDRH has played in serving the American people and putting our mission of protecting and promoting public health first. Our country, along with the rest of the world, is in the midst of an historic crisis and we have responded with historic actions. (For the numeric breakdown, see “CDRH’s COVID-19 Response by the Numbers.“)
Emergency Use Authorizations
As medical devices, particularly diagnostic tests, are the first line of defense against an emerging outbreak, CDRH was the first FDA center to utilize the agency’s authority to issue Emergency Use Authorizations in this pandemic. In particular, CDRH reviewed submissions in record time when few tests were available, including a 24-hour review process for several tests. The number of EUAs for COVID-19 dwarfs the total number of EUAs issued for previous public health emergencies. At the same time, the volume of traditional, non-COVID-19 submissions received has not changed, resulting in over 10,000 COVID and non-COVID submissions received by CDRH since January 1, 2020. The vast range of devices, including diagnostic tests, PPE, infusion pumps, ventilators, and other devices authorized under these EUAs, have been key in the public health response to the pandemic.
Given the incredible need for large volumes of critical medical devices for the public health response, CDRH developed policies with unprecedented regulatory flexibility to help expedite access to devices and focus the FDA’s resources where they would have the biggest impact. This began with EUA templates in January – a voluntary tool intended to facilitate validation of a test and submission of an EUA – weeks before the public health emergency was declared. The first EUA template was provided to a test developer on January 22, and the FDA posted a notice on its website of the template’s availability on January 27. By the end of January, 22 developers had requested and received an EUA template. This rapidly ramped up, with over 50 developers receiving a template by mid-February and almost 100 by the end of February. This was followed by the February 29 testing guidance that provided flexibility to laboratories offering validated diagnostic testing prior to submitting an EUA request. To date, CDRH has issued 10 EUA templates and 23 guidance documents, including for products ranging from remote monitoring devices to various forms of PPE. Through these templates and guidance documents, CDRH has helped firms increase access to critical products and has provided streamlined recommendations to expedite FDA review and authorization. At the same time, CDRH monitors the appropriateness of these policies on an ongoing basis and has updated several documents to continue to strike the right balance in its flexibility as the pandemic has evolved. CDRH also utilized new approaches for EUA issuances. For example, CDRH developed the novel concept of an “umbrella” EUA that authorizes the emergency use of similar devices that meet explicit criteria outlined in the applicable letter of authorization and has employed this concept by issuing umbrella EUAs to streamline the emergency authorization of dozens of ventilators and respirators, among other devices.
Shortage Mitigation Activities
Although CDRH has limited authorities regarding medical device shortages or specific funding for related activities, CDRH implemented a coordinated response to help address potential device shortages that came with the increase of global demand and supply chain disruptions that resulted from COVID-19. However, without similar authorities compared to the FDA’s drugs program, only about one-third of facilities that were contacted responded even in part to CDRH requests, hampering our shortage mitigation efforts. For example, early on, laboratories ran into challenges securing testing supplies, including swabs, transport media, and RNA extraction reagents. In partnership with the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD), CDRH helped to coordinate a series of military airlifts of millions of swabs in northern Italy, where they were manufactured, for nearly six weeks starting in mid-March. CDRH also helped labs and commercial manufacturers resolve shortage issues by coming up with supply alternatives and posted scientifically valid alternatives on our FAQ website so that all labs could benefit from each other’s findings. In March, CDRH was granted certain shortage authorities in the CARES Act, which aim to prevent or mitigate medical device shortages during a public health emergency. This includes a requirement for the FDA to maintain a publicly available, up-to-date list of the medical devices we have determined to be in shortage or were notified that manufacturing has been permanently discontinued. We publish this medical device shortages list to provide transparency to the American public, particularly those who use and/or purchase medical devices.
Public Health Service Commissioned Corps Deployment
Along with other Public Health Service (PHS) Commissioned Corps officers, CDRH PHS officers have been deployed to support the COVID-19 response, including assisting at testing centers as well as direct patient care. In addition to supporting the broader health system response to COVID-19, these efforts have provided valuable feedback about the needs of health care workers on the frontline. By having this direct feedback from staff on the frontlines, CDRH has been able to incorporate into policy considerations lessons learned on the ground as well as ongoing challenges.
Engagement with Stakeholders
CDRH established multiple communication channels during the pandemic, both to assist stakeholders and to keep a finger on the pulse of evolving needs and concerns in the medical device community in order to adapt appropriately. For example, CDRH has worked with over 500 test developers, providing the opportunity to receive feedback in real-time, as well as to submit data on a rolling basis through the pre-EUA process. CDRH also established multiple COVID-19 medical device-specific mailboxes through which they have received more than a quarter million inquiries since March and established a 24/7 toll free hotline in which they fielded calls related to diagnostic tests as well as availability concerns about medical devices in general from a wide range of stakeholders, including commercial manufacturers, laboratories, importers, health care providers, patients, caregivers, and states. CDRH’s Office of Communication and Education (OCE) saw their industry and consumer helpdesk interactions more than double in March due to COVID-19. OCE holds weekly and bi-weekly Virtual Town Halls to present new information and answer questions from stakeholders and updates the CDRH website regularly with new FAQs and with additional EUA templates as they are developed. CDRH speaks regularly with CDC, NIH, DoD and laboratory and health care professionals to discuss regulatory issues and the data necessary to rapidly advance development of products essential to supporting response efforts, gain valuable insight as the situation in the field continually changes, and identify areas where CDRH policy or engagement could help the public health response.
While incredible work is being done across the FDA in response to the COVID-19 pandemic, I am very proud of CDRH’s historic response, continually adapting and innovating to meet the public’s health care needs as the pandemic continues to evolve. Their work has been, and will continue to be, a critical part of the U.S. response.
For regular updates on CDRH’s efforts and the FDA’s COVID-19 response, visit: www.fda.gov/medical-devices.
Featured image: The FDA Center for Devices and Radiological Health’s COVID-19 response by the numbers between January 1 and September 18, 2020. (Credit: FDA)