Dive Brief:

• Jeff Shuren, director of FDA's Center for Devices and Radiological Health, stressed the need for increased funding and systematic changes of medical device review processes to ease the burden on a center that's "resource-strapped," understaffed and burning out due to the dual pressures of COVID-19 priorities and traditional workloads.
• Shuren, speaking Thursday at a virtual event held by the Alliance for a Stronger FDA, said that CDRH should be back to normal by the end of 2021, with some remaining work and backlogs lingering into 2022. However, the director said increased funding and systematic changes will be required to keep up with not just the continuing COVID-19 work but also regular priorities. "[The pandemic] put tremendous strain on the system, and it's really shown the limitations in the system," Shuren said. "There's not a lot of give."
• Regarding the delta variant of the coronavirus, which is causing surges in the U.S. and multiple countries, Shuren said the agency is concerned but did not directly address whether the variant will impact the accuracy of COVID-19 tests on the market. The director said CDRH has been analyzing multiple virus variants as early as March 2020 and reaching out to manufacturers about additional product assessments if test performance was possibly being adversely affected.

Dive Insight:

The pandemic quickly led to an increased workload for the FDA as the agency scrambled to craft new policies under the public health emergency and submissions for COVID-19 devices skyrocketed throughout last year.

As a result of focusing on coronavirus-related work, the CDRH fell behind on traditional priorities and backlogs built up. CDRH received 7,000 emergency use authorization requests and pre-EUA requests and 25,000 pre-market submissions since roughly last March, according to Shuren.

In December, Shuren said CDRH is looking to 2021 as a "reset," and so far the center has been able to gain some ground. 

Certain CDRH staff members who were focused on COVID-19 tasks have been moved over to submissions that were delayed, and each delayed submission has been given a lead reviewer, according to Shuren. However, the center is still declining certain application reviews, such as in vitro diagnostic submissions. Presubmission meetings with manufacturers for IVD devices are only being held if they are COVID-related, breakthrough devices-related or companion diagnostics-related.

"We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us. That's the trade-off. But, hopefully, sometime in 2022 we'll get back on track," Shuren said. "The big unknown: how much more keeps coming in for COVID, since we keep getting submissions, and how many of those that we've authorized will come in the door for full marketing authorization."

Getting back on track, however, has come at a cost.

"Our folks gave all they had and more to get the job done, but they have been burned out as a result," Shuren said.

The strained working conditions due to COVID-19 highlighted needed areas of change even in a post-pandemic environment, such as increased funding and regulatory or systematic changes.

On the regulatory side, the director said that more flexible review processes are needed going forward. One strategy used during the pandemic has been real-time application reviews with manufacturers as part of EUAs, which Shuren said is currently "unsustainable" but could be used in a targeted manner if resources allow as some manufacturers have favored the process.

Another regulatory change could help prevent future device shortages, which Acting FDA Commissioner Janet Woodcock advocated for before Congress on Tuesday. The agency has requested $21.6 million for such a system in its fiscal year 2022 budget request.

The system would require manufacturers to notify the FDA about potential supply shortages, a substantial change from the current process, which has no reporting requirements for manufacturers. The program would require funding to establish and expand authority for the FDA to require reporting.

Shuren contends that roughly one decade of flat funding has dropped the center's purchasing power because it has not kept up with inflation, although there have been certain targeted funds sent to CDRH. The lack of funding increases has hampered the center's ability "to meet the current needs that we see today, let alone be well-positioned to address the technologies that we know we'll be coming to us soon or in the distant future."

CDRH's funding increased from approximately $448 million in fiscal year 2017 to $628 million in fiscal year 2021, according to a June report from the Congressional Research Service. Over this time, the center's portion of the FDA budget has remained at about 9-10% each year.

President Joe Biden's 2022 budget proposal, which is a wish list needed to be approved by Congress, requests $677 million for CDRH, about 9.7% of the FDA budget, according to the report.

Shuren specifically pointed out postmarketing safety and quality reviewing as an area that additional funding should go toward.

"Quite frankly, many in the public — some in industry, some elsewhere — are just used to us being underfunded and somehow always pulling off a miracle," Shuren said. "I will tell you that after having gone through the pandemic … there are essentially no more rabbits to pull from our hat." 

Increasing the center's staff and hiring leading experts is another area where the director said increased funding is needed.

Shuren said in order to hire and retain leading experts, the agency should allow for remote work and professional development, provide a good work/life balance and offer a higher, more competitive pay than it currently offers.

"If we continue to treat people as if they're in a sweatshop, quite frankly, it will continue to be difficult to get the best and the brightest," Shuren said.