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 (OPEQ), CDRH
Since the onset of the COVID-19 pandemic, staff at the FDA’s Center for Devices and Radiological Health (CDRH) have worked tirelessly to manage unprecedented workload demands to help increase access to high quality, critical products that are essential to our nation’s pandemic response. Last April, we highlighted our prioritization of work related to COVID-19 response, which resulted in some delays in other work areas. Our pandemic response has remained a top priority for CDRH, and the COVID-19 workload continues to strain center resources. To date, we’ve issued marketing authorization to over 1,900 medical devices for COVID-19, including 15-times more Emergency Use Authorizations (EUAs) for this public health emergency (PHE) than all other previous PHEs combined. We also continue to receive more than 100 EUA requests per month. As we head into 2022, CDRH will continue to transition toward resumption of normal operations.
Sustained Increase in Submissions and Workload
For the second consecutive year, CDRH experienced an increase in the number of “conventional” premarket submissions (510(k)s, De Novos, Premarket Approvals (PMAs) and Q-Submissions (Q-Subs)), receiving close to 18,000 submissions in Fiscal Year (FY) 2021. In addition, while the number of pre-EUA and EUA submissions declined from FY20 to FY21, we still received more than 2,200 in FY21. This two-year “sprint” (more aptly described as an ultra-marathon) has facilitated the availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices to prevent, diagnose and treat COVID-19 related symptoms. However, the sustained high volume continues to strain center resources.
We’ve previously described the steps we’ve taken to address the large increase in work volume, including adopting agile, interactive and innovative approaches to review of EUA requests. We’ve published dozens of guidance documents and “EUA templates” to clarify agency recommendations and streamline review. We’ve implemented a front-end triage process to identify devices that would have the greatest impact on public health, and we’ve reallocated our staff and resources from product areas less impacted by COVID-19 to those with increased submission volume. We’ve made use of overtime, leveraged contractors from outside organizations to supplement our review staff and used funding support from Congress to hire additional staff.
Given the heavy workload from conventional submissions that pre-dated COVID-19 and COVID-19 response work, we continue to experience some delays in meeting review timelines for certain submissions, including files tied to Medical Device User Fee Agreement (MDUFA) timelines.
Review of Non-In Vitro Diagnostic (non-IVD) Products
CDRH divisions reviewing submissions for PPE (for example, respirators, facemasks, gowns, gloves), ventilators and general hospital equipment have experienced extraordinary increases in workload. For example, our PPE review teams received more than 400 510(k)s in FY21, representing a 6-fold increase compared to pre-pandemic volume. We’ve reassigned staff from less impacted product areas to assist our teams in these heaviest hit divisions and we continue to rely on overtime and leverage contractor review assistance. Throughout FY21, pre-submission reviews have generally been completed in these divisions within 120 days – approximately 7 weeks longer than the pre-pandemic average. Likewise, our ability to review conventional premarket submissions for non-IVD products (such as 510(k)s, De Novos, and PMAs) within MDUFA timeframes has also been affected. During 2022, CDRH expects non-IVD review divisions to be able to transition back to most of the MDUFA review timeframes, although some submissions may experience delays on a case-by-case basis.
Review of In Vitro Diagnostic (IVD) Products
Since the start of the pandemic, the unprecedented number of EUA and pre-EUA submissions that we received for COVID-19 tests and collection kits significantly impacted our workload, particularly our ability to review IVD submissions that were not related to COVID-19 (non-COVID-19 IVDs). These divisions still carry a heavy workload due to the high number of EUA and pre-EUA submissions for COVID-19 tests and collection kits, despite our reallocation of resources to this group (including newly hired staff) and streamlined review process changes.
As we head into 2022, we continue to receive more than 100 IVD pre-EUA and EUA submissions per month. As a result, we expect to receive more than 1,000 IVD pre-EUA and EUA submissions in 2022, and the pandemic-related volume of submissions could far exceed this number if additional COVID-19 variants of concern are identified. Nevertheless, we will make our best attempt to transition back toward normal operations and pre-COVID IVD review timelines in 2022. Currently, CDRH is accepting and immediately initiating the review process for all new IVD 510(k), De Novo and PMA premarket submissions. Although we had previously paused review of some non-COVID IVD marketing submissions, review resumed as of June 2021 and all submissions previously paused due to resource constraints have completed review or are under active review. Due to the workload, timelines for non-COVID IVD marketing submissions, particularly 510(k)s, are extended. Sponsors can expect to receive the name of and contact information for their lead reviewer and projected review timelines within 30 days of submission receipt. Over the course of 2022, we anticipate transitioning back toward completion of submission reviews within the timelines for FDA review set by our MDUFA commitments.
In the April 2021 FDA Voices, we announced that we were declining IVD pre-submission requests unless they were related to COVID-19, a companion diagnostic, a breakthrough device designation request, or an IVD that would have a significant public health impact. We’re pleased to announce that, as of January 1, 2022, CDRH plans to also accept pre-submissions requesting feedback for IVDs that require or would be likely to require a PMA or De Novo submission. Depending on the course of the pandemic, we hope to be able to accept all IVD pre-submission requests by the late spring or early summer. Although it’s likely these IVD pre-submissions will initially be reviewed under an extended timeline, we expect to transition toward normal MDUFA timelines during the course of 2022.
Workload and Resources in 2022
While CDRH’s response to the pandemic remains a top priority, we anticipate a gradual transition back toward normal review timelines in 2022. Our ability to reach and sustain “normal” review times will depend on the course of the pandemic and adequate resources, and we appreciate your patience and understanding while we continue to respond to the public health emergency. CDRH will continue to keep stakeholders apprised of these phased transitions through periodic updates.