Shuren previews 2021 priorities for CDRH

Regulatory NewsRegulatory News
| 03 December 2020 | By Michael Mezher 

Jeffrey Shuren, Credit: US FDA

With much of his center’s 2020 agenda on hold due to the COVID-19 pandemic, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiologic Health (CDRH) on Thursday shared some of his hopes for next year on a call with the Alliance for a Stronger FDA.
“COVID-19 has essentially disrupted the trajectory of the medical device program in 2020. If you really think about it, 2021 is going to be a bit more of a reset,” Shuren said, adding that the center will extend its strategic priorities for 2018-2020 into 2021.
Shuren said that CDRH is “continuing the course in part because of the impact of the pandemic—a lot of our work we’ve been doing has been delayed—so we’re not really in that position for some of the really big changes.”
The “reset” year will also give the center time to learn from its experience during the pandemic and comes as the agency prepares for the negotiations that will shape the next iteration of the Medical Device User Fee Act (MDUFA V) program.
“That may inform where we go as a center so that we are well-positioned to implement the commitments coming out of those discussions — ultimately legislation — in FY2023,” Shuren said.
Shuren took time to defend the center’s approach to speeding devices for COVID-19 to the market, including diagnostics, ventilators and personal protective equipment, and said the workload has had an impact on the center’s non-COVID activities. “The number of pre-[emergency use authorizations] EUAs and EUAs together since the start of the pandemic has been over 5,000,” Shuren said, noting that the center has issued more than 600 EUAs to COVID-related products so far.
At the same time, Shuren said the center’s workload for non-COVID-related devices has held steady. “If anything, we’re getting more submissions for innovative technologies. That is good on one hand that that innovation pipeline isn’t drying up — maybe even getting better — but at the same standpoint, just a massive increase in work that’s come our way,” he said.
Shuren noted that the center has exceeded its goal of seeing at least half of devices using novel technologies launching in the US first or in parallel with other major markets. “In the first half of 2018, about 51% claimed to do so. That number has steadily increased: in the first half of 2020 that number was 69%.” But Shuren warned that without “important changes” in the coming year, that number may dwindle because of the impact of COVID-19 on the center’s premarket review program.
Shuren said that premarket review times for non-COVID-related devices have increased and the agency has had to postpone meetings with a number of companies in order to prioritize the pandemic response.
Looking forward to MDUFA V, which will largely be negotiated with industry in 2021, Shuren said his hope is to “not stay focused on the more traditional things … like performance goals around premarket review. Let’s instead think about where we want the ecosystem to be at the end of MDUFA V.”
Shuren said that CDRH will begin testing a system that would allow companies to track the progress of their submissions using a FedEx-style tracker. “We’re going to start in January with more of a soft-launch with a handful of developers,” Shuren said, noting that a full launch could take place next spring.
Shuren teased a number of actions the center is hoping to take next year, including finalizing guidance on clinical decision support software and patient-reported outcomes, expanding its Case for Quality voluntary improvement program and developing an action plan and draft guidance on artificial intelligence and machine learning.
Shuren also said that proposed rules for aligning US quality system regulations more closely with the international quality system standard ISO 13485:2016 and over-the-counter hearing aids that were delayed this year are a high priority for the center and may see the light of day in 2021.
However, Shuren said that both ISO 13485 alignment and the center’s 510(k) modernization aspirations would need the blessing of the Biden administration before moving forward. “I don’t want to get too far ahead of myself. There’s a new administration coming in the door, they need to put eyes on the work that we’re doing,” he said.


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