A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response

If you want to know the U.S. Food and Drug Administration’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.