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Shuren: Time to rethink the regulatory framework for FDA devices

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Rethinking the regulatory framework for medical devices has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration (FDA), particularly at the in light of the lessons learned by the agency. during the COVID-19 pandemic.

When he became director of CDRH in 2009, Shuren said the medical device industry was in a different place. “Innovators were bringing their technologies overseas, primarily because of increased review times and the lack of predictability and transparency in the FDA’s pre-market review process.” , he recently told AdvaMed President and CEO Scott Whitaker of the MedTech POV Podcast. Since then, CDRH’s goal has been to give patients in the United States access to “high-quality, safe and effective” devices while “advancing medical device innovation and ensuring patients rapid access to devices of importance to public health ”.

Although there was an innovation ten years ago, “In the last five years or so, I have never seen things accelerate so quickly. This is the trajectory we are on, and I expect the increasing pace of innovation, certainly for emerging science, to continue, ”said Shuren.

He noted that the FDA must be ready for this innovation. “I think we have to think of a different kind of FDA if we are to be well prepared to deal with the kinds of emerging science that we are seeing today,” he said. “It’s not just about having the enabling technologies that we can use. It will even amount to rethinking the regulatory paradigms that we apply to more modern technologies. “

It starts by looking at how the 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 from the COVID-19 pandemic is regulatory flexibility, Shuren said. The FDA was able to use emergency use authorization authorities after a public health emergency was declared, allowing the agency to quickly adapt to changing circumstances. In addition, the FDA was in close contact with the sponsors, engaging with them early on and often in a pre-emergency use authorization process where “developers could interact with the center’s experts in real time through through emails and phone calls; they could provide data for review on an ongoing basis.

“Because of this regulatory flexibility and commitment, the development review and authorization of the devices has happened much faster than would otherwise happen under a standard review,” he said. declared.

This type of flexibility and communication between the CDRH and the sponsors should be in place when there is no 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 the level of regulatory flexibility we had with COVID a routine practice by having the ability to adapt the regulatory paradigm of evidence required for a marketing authorization. complete market to the technology and its use. in the cheapest way, he said, adding that any new process would still meet the current US standard of “reasonable assurance of safety and effectiveness.”

Some sponsors appear to prefer the current regulatory environment to the environment that existed before the pandemic, Shuren said; he sees this as a possible future. “Some companies have told me that they never want to go back to the situation without COVID. For us, this is something we need to talk about. We want to have that kind of commitment, ”he said.

Shuren sees “big threats” in the future when it comes to innovation. “We need to think about how this engine of innovation in the United States remains supercharged. If we can really make… this time of development, evaluation and beyond much shorter and much more predictable, you’re going to invest more in medical technology. It’s really going to keep the engine running, ”he said.

Objectives for MDUFA V

Commenting on the upcoming Medical Device User Fee Modification Program (MDUFA V), Shuren said the MDUFA reauthorization is an opportunity to address engagement and work with developers, “to have the ability to stay at the forefront of science, but also to understand what developers are doing with their technology. (RELATED: MDUFA V: Industry wants fine-tuning as FDA seeks to expand, Regulatory guidance October 27, 2020).

“MDUFA V could be where we have this dialogue and see if… rather than going back to the pre-pandemic engagement, do we want to go back to a new kind of engagement that is informed by what we’ve been through during the pandemic, ”he said. mentionned.

Whitaker and Shuren agreed on the need for a bipartisan effort to re-authorize MDUFA through Congress to foster innovation for patients. “Having that spirit of collaboration and having a dialogue could maybe get us to where, through MDUFA, we have the ability to have a whole different kind of ongoing dialogue and collaboration,” said Shuren.

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