Dive Brief:

• Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said at an event Thursday that in light of the pandemic's disruptions to CDRH's 2020 medical device priorities, next year will be more of a reset as the center looks to both manage coronavirus response-oriented work and move forward with projects unrelated to COVID-19.

• CDRH has been overwhelmed by a "massive increase" in work during 2020 by COVID-19 efforts such as granting emergency use authorizations for diagnostic tests. But non-coronavirus submissions have also continued to pour into the center at the same or higher rates than previous years, according to Shuren, speaking during a virtual event hosted by the Alliance for a Stronger FDA.

• Along with continuing to manage COVID-19 work, Shuren said the priority list for 2021 will include addressing the next round of the medical device user fees program (MDUFA V), applying regulatory flexibilities used during the pandemic to traditional processes, and launching or piloting multiple programs such as the Safer Technologies Program.

Dive Insight:

One of the largest hurdles for CDRH will be overcoming the workload that has stretched the center's resources thin.

Those resources have gone not just to reviewing and authorizing emergency use submissions, but also working closely with developers and holding dozens of webinars to help industry members get products to market, Shuren said. While this work is necessary, it has also slowed down the review process.

"The ripple effect is that we are now starting to see our performance on our traditional submissions — like 510(k)s and [premarket authorizations] — the time it is taking to reach a decision is starting to go up, putting at risk our ability to meet our commitments under the user fee program," Shuren said. "And, a number of the other things that we're engaged with...are starting to slow down or going on the back burner because COVID-19 is the top priority."

Shuren added CDRH expects "those challenges are only going to get worse." For one, the director anticipates a new hurdle in the coming months will be developers seeking full marketing authorization for COVID-19 products.

Another hit from COVID-19 could be a drop in the number of device makers with new technologies that plan to first launch a product in the U.S. over other regions. The fraction of developers with FDA-authorized products first or at least co-launching in the U.S. increased from about 51% in the first half of 2018 to 69% in the first half of 2020, according to Shuren. However, this number may decrease due to the pandemic's effect on the FDA.

Looking ahead to next year, addressing MDUFA V will be a top priority for the center. User fees from industry are meant to support FDA's work to achieve faster and more predictable review and authorization timelines. The first public meeting to discuss the MDUFA V reauthorization was held in October after being delayed over six months due to the pandemic.

Shuren stressed that the conversations should not be held in a vacuum or focused on more traditional topics like performance goals for pre-market review.

"Let's instead think about where do we want the ecosystem to be at the end of MDUFA V, maybe even MDUFA VI, and then work backward to say how can we best leverage the user fee program to best address achieving that outcome," Shuren said.

Launching the Safer Technologies Program (STeP) will be a top goal early next year. The program focuses on getting devices to market that could be significantly safer than existing treatments or diagnostics for diseases or conditions less severe than those targeted by the Breakthrough Devices Program.

Shuren said that like the Breakthrough Devices Program, developers using STeP will be offered more engagement and additional resources throughout the review process.

FDA also plans to launch a tracking program for products undergoing premarket review. Shuren likened the program to FedEx's package tracking software, allowing developers to follow a submission through the entire review process. A soft launch will begin in January, and a full version of the program will be available in the spring.

The director also said that enhancing the 510(k) pathway may become a reality in 2021, especially with a new administration taking over in January. Shuren highlighted an alternative pathway for the 510(k) program already created by CDRH called the Safety and Performance Based Pathway, which is voluntary and is still in its early stages. Rather than comparing a product to a predicate device based on technology, developers can compare products based on performance, which Shuren said gives developers an opportunity to show that their product works better than others currently on the market.

Much like during an October talk at an AdvaMed event, Shuren said CDRH needs to implement lessons learned during the pandemic and embrace the same regulatory flexibilities going forward that it has shown in response to the coronavirus crisis. One key area for the center will be the speed of the review and clearance or approval process, and also quickly releasing guidance documents.

"It's those kinds of flexibilities that are things that we think are important not just to continue in the pandemic, but also to do this in peacetime," Shuren said, noting that the FDA's current medtech regulatory authorities are more than 40 years old and are not flexible enough for today's technologies with rapid innovation cycles.