By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, CDRH
The response to the COVID-19 pandemic by the medical device industry and the clinical community has been impressive. Throughout the public health emergency, staff at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have worked tirelessly and strategically to meet unprecedented workload demands and to help provide access to high quality, critical products that are essential in protecting the public health. We authorized a record number of novel medical devices in 2020 and have issued 10-fold more Emergency Use Authorizations (EUAs) during COVID-19 than all other previous public health emergencies combined. However, this means that we are also prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.
Impact of CDRH’s COVID-19 Workload on “Conventional” Review in 2020
The FDA made unparalleled contributions to the public health in 2020. At CDRH, not only did we experience an increase in “conventional” premarket submission types (510(k)s, De Novos, Premarket Approvals (PMAs), and Q-Submissions (Q-Subs) to over 17,000 files, we also received over 5,500 pre-EUA and EUA submissions. This resulted in an overall increase in premarket submissions of 38%. We helped facilitate the development and availability of a historic number of EUAs for COVID-19 tests and collection kits, personal protective equipment (PPE) to help control the spread of the disease, as well as ventilators and other devices for treating COVID-19 related symptoms. Since the start of the pandemic, we have issued EUAs or granted full marketing authorization to almost 1,300 medical devices for COVID-19. In addition, we conducted timely review of more than 2 million medical device adverse event reports and completed other pivotal work activities such as addressing supply chain shortages and counterfeit products related to COVID-19.
Not surprisingly, this unprecedented workload began to significantly strain center resources as we continued to prioritize COVID-19 work, particularly in the review of in vitro diagnostic (IVD) files. This is the office within CDRH that has been impacted the most from the beginning of the pandemic due to the astounding number of pre-EUA and EUA submissions received for COVID-19 tests and collection kits. The divisions in charge of reviewing premarket submissions for ventilators and other respiratory support devices, as well as PPE, were also hit hard.
As of today, the list of pre-EUA and EUA submissions under active review across the center still tops the 600 mark and we continue to average receipt of more than 40 new pre-EUA and EUA submissions per week in addition to our “normal” submission volume. This has resulted in a backlog of non-COVID-19 premarket files pending review.
Prioritizing Work to Address the Increase in Volume
Since early 2020, we have taken steps to address the large increase in work volume so we could attend to the enormous magnitude of COVID-19 related submissions. First and foremost, we have adopted agile, interactive and innovative approaches to EUA review, publishing 13 “EUA templates” that have been revised 11 times to help clarify the agency’s expectations to streamline review, where possible. We implemented the development of umbrella EUAs for more efficient authorization of multiple devices of the same type following the same criteria. We have also issued 28 guidance documents that have been revised 17 times outlining policies to help expand the availability of medical devices needed in response to COVID-19. Further, we made several improvements to our EUA review processes to make the most efficient use of our resources, including establishing a front-end triage process to identify devices that would have the greatest impact on the public health. These improvements incorporate our growing information on device availability and shortages, prioritizing novel or critical devices not yet available on the market or those that would address significant device shortages, and applying review structures as used in other submission types to help guide review staff on expected milestones.
While specific product areas have been more impacted by the COVID-19 pandemic than others, every office in CDRH has been heavily impacted because we have reallocated our staff and resources from product areas less impacted to those with increased submission volume. In total, more than 50% of our staff and managers have been directly involved in CDRH’s COVID-19 response while many others picked up extra non-COVID-19 work to support the response. Our staff have been working nights and weekends to keep up with the work volume, all the while dealing with pandemic-related challenges themselves at home. We have also used one-time funding support from Congress to hire term employees and use third party reviewers.
Through it all, we continue to focus our attention on activities and review work that will have the greatest impact on public health. Specifically, we are prioritizing the review of devices that will provide the most benefit to patients, consumers and health care personnel.
Despite all these efforts, we expect delays in meeting review timelines for certain non-COVID-19 submissions, even for files tied to Medical Device User Fee Amendments (MDUFA) commitments.
Delays in Reviewing IVD Submissions and Pre-submissions
Unquestionably, our biggest review challenges have been in the IVD product space due to the enormous volume of EUA submissions. In the last year, we’ve already taken extraordinary steps to prioritize the review of COVID-19-related IVD submissions. Unless IVD pre-submissions are related to COVID-19, companion diagnostics, a breakthrough designation request, or have a significant public health impact, we have been unable to review them. We have tried to utilize all the tools at our disposal. However, for the remainder this year, we will be declining other IVD pre-submission requests that don’t fall into these categories for the present time. In addition, non-COVID-19 IVD submissions are experiencing longer-than-typical review timelines and delays in initiation of review. We anticipate eliminating review initiation delays on non-COVID-19 IVD files within the next 8 weeks, and will be providing sponsors with the name of and contact information for their lead reviewer and projected review timelines within 30 days of submission receipt. While we’ve never had to take such actions in prior public health emergencies, we've also never experienced a pandemic like this one.
Review Delays in Non-IVD Product Areas
Divisions reviewing files for PPE (e.g., respirators, facemasks, gowns, gloves), ventilators, and general hospital equipment have also experienced significant increases in workload, although they have been able to continue to meet MDUFA timelines for most marketing submissions. These divisions are experiencing longer review timelines for pre-submissions. We anticipate pre-submissions in these divisions to be completed within 120 days, rather than the usual 70 days. Premarket submission reviews and pre-submissions in other product areas are generally continuing under typical timelines although a small number of submissions may experience delays on a case-by-case basis.
COVID-19 Work Remains a Priority
We will continue to prioritize work related to COVID-19. We look forward to our continued interactions with device submission sponsors and appreciate your patience and understanding while we continue to respond to the public health emergency.