CDRH's Shuren warns of the 'canary in the coal mine' in the FDA's COVID-19 response

FDA
"If I had to do it over again, I would never do it over again," said the FDA's device center director Jeffrey Shuren during a town hall meeting at AdvaMed's virtual conference. (FDA)

The FDA has found itself between overwhelming public demand for COVID-19 diagnostics, ventilators and other devices on one side, and a tsunami of companies submitting over 1,200 products for review on the other—and the workload is beginning to take its toll. 

The agency has had to reprioritize programs and shuffle staff among its review teams to keep those applications moving, and the strain has started to slow the processing of medical products outside of the novel coronavirus, according to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. 

“Obviously COVID-19 is all hands on deck—but we are starting to see our performance on some of our submissions starting to slip, and it really is a canary in the coal mine,” Shuren said during a town hall meeting at the Virtual Medtech Conference hosted by AdvaMed, the industry’s trade association. 

“We are starting to see an uptick in our review times for [premarket authorizations], for example,” he said. “The backlog is starting to go up, and we know that will start to build a bit overtime. The same thing is decreasing performance for 510(k) clearances.” 

So far, the FDA has authorized about one coronavirus test each day on average, Shuren said, and over 500 tests and devices in total—far more than it has greenlit for all prior outbreaks and public health emergencies combined.

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And while the agency has been able to meet its goals for moving companies through the pre-submission process, beyond that the FDA can’t make the same commitments to meeting timeframes, based on the high volume they’ve received. 

“We have many people working long hours, weekends and evenings, and we pull people from less-impacted offices,” said William Maisel, CDRH chief medical officer and director of the FDA’s Office of Device Evaluation.  

“But because they've given up some of their staff to help with the surge, it really is something that’s impacting our performance throughout the entire organization,” Maisel said. “I will also say we do have staff members and their families who have been impacted by COVID themselves.” 

In addition, granting an Emergency Use Authorization doesn’t mean the job is done. Those products may come around again for a full marketing approval or clearance, after the pandemic has begun to subside. 

When that time comes, the regulatory flexibility granted to the FDA during the public health emergency may serve as a model for a more-nimble system for product reviews going forward, Shuren said. 

“A challenge we face is that the regulatory paradigm established with medical devices is over 40 years old, and is not well-suited for many modern-day technologies,” including products with rapid innovation and development cycles, he said. 

“As we look to the future, we should consider how to make this level of regulatory flexibility” a routine practice, Shuren said, by “tailoring the regulatory paradigm and the evidence required for full marketing authorization to the technology and its intended use—as well as by rapidly developing and issuing guidance to establish and adjust policies in near-real-time, as circumstances warrant.” 

“We really should think about—does the agency have the right tools to provide that level of flexibility, so that we're not just in parallel with the emerging science, but out in front of it,” he said. “There were times where that opportunity to engage in essentially real time truly could make the difference. If that's going to work though, we have to be smart where we do it, we have to have the capacity to do it, and we have to have shared expectations.” 

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