- Having a well-defined pathway to quickly review and provide clearance for low-risk devices will help alleviate the backlog and shift resources to more critical and high-risk device applications.
- As the pace of innovation increases and the number of novel devices brought to market continues to grow, keeping up with reviews will remain an ongoing challenge for the FDA.
In December the FDA announced anticipation of a gradual transition to normal review timelines in 2022 for medical device approvals. Timing will depend largely on the future impacts of the COVID-19 pandemic. We noted in our Jan. 3, 5 things to know in life sciences, that the FDA had temporarily paused factory inspections due to the recent surge of COVID-19 cases. Consequently, we expect this recent wave will further shift the return of normal processing times to the latter part of 2022, with the potential to spill into 2023 if additional challenges arise.
In 2021, application requests were above normal for the second consecutive year. For example, the FDA received more than a sixfold increase of 510(k) applications for personal protective equipment compared to pre-pandemic volume. We expect this trend will continue as investment and returns in the services sector outperform the general market and remain above average. To help alleviate the heavy workload, the FDA continues to reassign staff from low-priority reviews and has been leveraging overtime and contractor assistance. However, pre-submission reviews in 2021 still took an average of 120 days to complete, nearly 50 days longer than the pre-pandemic average.
Modernization of the regulatory framework will help
Prior to the pandemic, in November 2018, the FDA announced it would take steps to modernize the 510(k) clearance pathway in an effort to keep pace with innovation, streamline the approval process and address the nearly 20% of devices cleared based on technology greater than 10 years old. Of the various medical approval processes, the clearance pathway continues to make up the majority of applications. Further exacerbating the issue is an increase in total applications over the last 10 years, which we expect will continue as the pace of innovation increases and investment dollars grow.
In September 2019 the FDA took the first step toward fulfilling its 2018 modernization plan by establishing the Safety and Performance Based Pathway, focused on four specific device types:
- Conventional Foley catheters
- Cutaneous electrodes for reporting purposes
- Orthopedic nonspinal metallic bone screws and washers
- Spinal plating systems
The goal of the new pathway is to streamline the application process for certain well-understood device types, and to improve overall review times and safety across all devices. Having a well-defined pathway to quickly review and provide clearance for low-risk devices will help alleviate the backlog and shift resources to more critical and high-risk device applications.
Renewed calls for additional changes
Despite the recent FDA announcements, several articles this year have indicated additional measures are needed to properly reform the aging medical device regulatory framework. Specifically, a November 2021 JAMA Network article took a closer look at a recent device recall and outlined gaps that still exist in the recommendations put forth by the Institute of Medicine back in 2011. Earlier in 2021, another JAMA report detailed safety concerns related to the high number of recalls for devices with 510(k) clearance. Additionally, the report found that high-risk devices approved through the much more rigorous premarket approval pathway were also associated with a greater risk of recall than was previously understood.
The FDA now regulates more than 190,000 distinct devices. As the pace of innovation increases and the number of novel devices brought to market continues to grow, keeping up with reviews will remain an ongoing challenge for the FDA. The COVID-19 pandemic has exacerbated the problem as the number of new devices seeking clearance has increased significantly while resources available to review applications remain constrained. Despite the steps taken to modernize the regulatory framework and return to normal processing times, we do not believe these efforts will be sufficient to prevent a permanent increase in review times while also ensuring the highest level of product safety and limiting the number of device recalls.
In an upcoming article, we will take a closer look at the historical data, including number of device approvals by class, type and review time. We’ll look at ways to further streamline the process, including leveraging technology and clinical data to improve real-time reporting and device safety. As we expect the number of devices seeking clearance or approval to grow in lockstep with the rapid pace of innovation, the FDA must look for additional ways to streamline and modernize the medical device clearance and approval process.
