Shuren: Time to rethink FDA's device regulatory framework

Regulatory NewsRegulatory News | 23 June 2021 |  By 

Rethinking the medical device regulatory framework has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), especially in light of lessons the agency learned during the COVID-19 pandemic.
When he became director at CDRH in 2009, Shuren said, the medical device industry was in a different place. “Innovators were bringing their technologies overseas, first due to increasing review times and lack of predictability and transparency in the FDA’s pre-market review process,” he recently told AdvaMed President and CEO Scott Whitaker on the MedTech POV podcast. Since then, CDRH’s goal has been to give patients in the US access to “high quality, safe and effective” devices while also “advancing medical device innovation and assuring timely patient access to devices of public health importance.”
Although there was innovation a decade ago, “just in the past five years or so, I’ve never seen things accelerate so fast. This is the trajectory that we’re on, and I expect that increasing pace of innovation, certainly for emerging science, will continue,” Shuren said.
He noted that FDA needs to be ready for this innovation. “I think we have to think about a different kind of FDA if we're going to be well prepared to deal with the kinds of emerging science that we see today,” he said. “It’s more than just having the enabling technologies for us to use. It will come down to even rethinking the regulatory paradigms that we apply to more modern-day technologies.”
That starts with looking at how FDA regulates medical devices, according to Shuren. “The framework we use today was designed over 40 years ago. It was literally developed with my grandmother's technology in mind, not for the things we see today,” he said.
Regulatory flexibility beyond COVID-19
 A big lesson of the COVID-19 pandemic is regulatory flexibility, Shuren said. FDA was able to use emergency use authorization authorities after a public health emergency was declared, which gave the agency the ability to adapt quickly to changing circumstances. In addition, FDA was in close contact with sponsors, engaging with them early and often in a pre-emergency use authorization process where “developers could interact with center experts in real time through emails and phone calls; they could provide data for review on a rolling basis.”
“As a result of that regulatory flexibility and engagement, the development review and authorization of devices occurred much more rapidly than would otherwise happen under standard review,” he said.
This type of flexibility and communication between CDRH and sponsors should be in place when there isn’t an emergency. While it would require a change in the law, it would be a “game changer,” Shuren explained. “As we look to the future, we should consider how to make that level of regulatory flexibility that we had with COVID a routine practice by having the ability to tailor the regulatory paradigm of the evidence required for full marketing authorization to the technology and its use in the least burdensome manner, he said, adding that any new process would still meet the current US standard of “reasonable assurance of safety and effectiveness.”
Some sponsors seem to prefer the current regulatory environment to the environment that existed pre-pandemic, Shuren said; he sees that as one possible future.  “I've had some companies tell me they never want to go back to the non-COVID situation. For us, that's something for us to talk about. We want to have that kind of engagement,” he said.  
Shuren sees “big threats” in the future regarding innovation. “We’ve got to be thinking about how that innovation engine in the US stays supercharged. If we can really make… that time in development, evaluation, and beyond much more shortened and much more predictable, you’re going to drive more investment into medtech. That’s really going to keep the engine going,” he said.
Goals for MDUFA V
 Commenting on the next Medical Device User Fee Amendments (MDUFA V) program, Shuren said reauthorizing MDUFA is an opportunity to address engagement and working with developers, “to have the capability to stay on the leading edge with the science, but also understanding what developers are doing with their technology.” (RELATED: MDUFA V: Industry wants fine tuning while FDA seeks expansion, Regulatory Focus 27 October 2020).
“MDUFA V could be the place where we have that dialogue and see if…rather than going back to engagement pre-pandemic, do we want to go back to a new kind of engagement that’s informed by what we experienced during the pandemic,” he said.
Both Whitaker and Shuren agreed on the need for a bipartisan effort to reauthorize MDUFA through Congress to foster innovation for patients. “Having that spirit of collaboration and having dialogue could maybe get us to the place where through MDUFA, we have the capability to have a whole different kind of ongoing dialogue and collaboration,” Shuren said.


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