- FDA's Center for Devices and Radiological Health (CDRH) is aiming to achieve at least 90% of its annual center-wide hiring targets in its 2023 to 2025 fiscal years.
- The commitment, which CDRH made in a report on its 2022-2025 strategic priorities released Thursday, comes as the device center's resources continue to be strained by a COVID-19 workload and follows Medical Device User Fee Amendments (MDUFA) V talks that exposed industry concerns about the number of vacancies at the agency. FDA failed to send a MDUFA V agreement to Congress by the Jan. 15 deadline.
- Other commitments build on the objectives CDRH set out in its priorities for 2018 to 2020. Having met an earlier goal, the center is now aiming for more than 50% of novel devices to come to market in the U.S. first or in parallel with other major territories by the end of 2025.
Since the start of the pandemic, CDRH has struggled to manage an unprecedented workload by reallocating its staff and resources from product areas less impacted by COVID-19 to those with increased demand. The center has also made use of overtime, relied on outside contractors to supplement its review workforce and tapped funding from Congress to hire additional staff.
The pandemic's impact is evident in CDRH's 2022-2025 plan issued on Thursday.
One of the center's strategic priorities is the promotion of a modern and diverse workforce; another is the enhancement of organizational agility and resilience. CDRH framed both priorities as ways to improve its ability to adapt to change.
By enhancing its workforce and supporting them with digital collaboration tools, CDRH aims to "prepare the organization for future disruptions." Similarly, the center said "the COVID-19 pandemic brought home the importance of agility and resilience." The third priority is to advance health equity.
CDRH will measure its success against eight objectives, two for each of the strategic priorities and a further two overarching goals. The first overarching goal is for more than 50% of newly authorized novel devices to come to market in the U.S. first, or joint first, by the end of 2025. The goal builds on FDA's success in getting 50% of manufacturers to indicate their intent to target the U.S. first.
The second overarching goal is for CDRH to identify and act on significant medical device safety signals first or in coordination with other major markets 75% of the time. The center aims to hit that target by the end of 2025.
Other notable objectives include the 90% hiring target, which follows industry concerns about how many MDUFA-funded full time equivalent positions are vacant at FDA. The industry used the MDUFA V talks to call for CDRH to establish hiring targets "to ensure there is transparency as well as prioritization within the agency to meet those goals."
CDRH has also vowed to work more efficiently. By the end of 2025, the center aims to cut the time it spends on at least 10 core business processes "without reducing performance or adversely impacting outcomes."
Other goals include releasing data stratified by demographic characteristics in premarket authorization decision summaries, improving understanding of communications "across diverse demographic groups," and a pair of objectives focused on staff satisfaction.
CDRH's dual pressures from COVID-19 priorities and traditional workloads has taken a toll on its workforce. Jeff Shuren, the center's chief, last year described CDRH as resource-strapped, understaffed and burning out.
"Our folks gave all they had and more to get the job done, but they have been burned out as a result," Shuren said.