On the backs of a waning COVID-19 pandemic and global supply chain disruptions, the FDA expects that a broader slowdown in the pace of medtech innovation will result in a dip in the number of new devices approved by the agency this year.
Speaking at an industry town hall during AdvaMed’s MedTech Conference in Boston, the FDA’s device center director, Jeffrey Shuren, M.D., said the drop in regulatory green lights compared to recent years would in part track with declines in the number of product applications the agency has received.
“We’ve heard from companies that things are just taking longer,” Shuren said. “We know industry has been hit hard with COVID—a lot of things got backlogged, like continuing data collection and getting submissions in the door. But we are monitoring this.”
Though the number of authorizations for novel devices has increased by more than fourfold over a span of 10 years—from 29 in 2010 to a highpoint of 132 green lights in 2020—that was driven in part by a tidal wave of submissions from companies looking to combat the spread of COVID, with 2020 applications up more than 60% versus the year before.
And despite including more than 1,400 requests for Emergency Use Authorizations (EUAs), this year’s total volume through mid-October has comparatively decreased to less than 20% over 2019’s.
“In the most recent quarter we saw an uptick, and hopefully that’s not a blip on the screen—hopefully, that reflects that things are back on the upswing,” Shuren said. “But keep in mind that we too have a bit of a backlog.”
Over the whole of the COVID pandemic, the FDA received over 8,000 emergency authorization requests, and granted green lights to more than 2,300 devices, including 444 diagnostic tests, through the end of September.
“It just reflects how disruptive all of this has been to both FDA and to the medtech industry.”
Now the FDA is preparing to shift its footing as the public health emergency comes to a close and the coronavirus becomes more endemic and potentially seasonal, similar to the flu. That will involve the developers of many COVID tests and products needing to obtain full marketing clearances as their EUAs expire.
The agency is currently working to finalize two draft guidance documents on transition policies, and Shuren said they are expected to be published within the next few months.
“One of the secret sauces on guidance is both the Trump administration and the Biden administration have made commitments to streamlining their review of guidances coming out the door,” he said. “We can put out guidances quickly. For the very first one we did during COVID on tests, we drafted and cleared it through the administration in 36 hours. So it can be done.”
“I hope that this is a lesson-learned for government—that we can cut the red tape and we can do this as business as usual. But don’t tell the administration I said that.”
The FDA also recently received “a shot in the arm” with the newest iteration of user fee legislation—a package of bills reauthorized every five years to help finance the agency’s work, with the latest taking effect October 1. Congress has also given the FDA new funding to hire more reviewers, Shuren said.
And when it comes to tracking supply chain concerns, the FDA also received COVID emergency money to stand up its first device shortages program.
“They’re not just disruptive to business or industry, quite frankly, the main thing is they put patients at risk,” Shuren said. “When we rolled into COVID we had had no dedicated funding provided to us for a supply chain program. We didn’t have a formal program per se, and we no authorities related to that.”
However, temporary emergency funds can only go so far, he said, adding that the FDA has seen shortages arise from issues completely unrelated to COVID. Now the agency is working to boost its base budget in that area.
“Not only so we can build but also sustain a resilient supply chain shortages program. It’s absolutely essential, not just for the device industry, but for our national economy and patient care at the end of the day,” Shuren said.
“We got some authorities from Congress in shortages, but it’s limited to a public health emergency—and I’m going to be blunt, it’s not good enough, because we see problems that are outside a public health emergency.”