Shuren: Let’s take regulatory flexibility beyond COVID-19

Regulatory NewsRegulatory News | 22 March 2022 |  By 

Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).
“There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s day-long webinar on artificial intelligence/ machine learning (AI/ML).
He noted that the FDA has been able to really step up during the public health emergency because of its ability to leverage its emergency use authorization (EUA) authorities. That kind of regulatory flexibility could be useful beyond the pandemic to get new products to market while also improving the agency’s mission to ensure reasonable assurance of safety and efficacy.
He argued that many of FDA’s powers were set by Congress at a time when lawmakers didn’t have to think beyond hardware-based devices. As more and more products have become software-based, it makes sense to update the agency’s regulatory powers.
With greater flexibility, “we really could tailor the regulatory pathway to the technology and that’s absolutely essential in digital health technologies which today are under these cookie cutter regulatory paradigms that were established in the law starting over 45 years ago and they literally were designed for my grandmother’s technology,” said Shuren. “I would love to see the law change to provide us the flexibility to give us this agile ability in our regulatory oversight that we had in COVID.”  
This isn’t the first time Shuren has broached the concept of greater statutory authority. He floated the idea back in 2019 during an AdvaMed conference where he said it would be helpful to the agency to have “regulatory Legos.” Instead of constantly asking lawmakers for new statutory authorities as technology advances, he argued, the FDA should have broader authority to bring new products not covered under its current authority to market.
Shuren hinted that he may seek to have broader authority included in the Medical Device User Fee Amendment (MDUFA V) deal; however, no language to that effect was included in the commitment letter FDA published for comment on 22 March.
Regulatory flexibility wouldn’t mean changing the FDA’s standards for marketing products based on reasonable assurance of safety and effectiveness but rather would be aimed at creating pathways that were least burdensome, risk-based and maybe most importantly voluntary so sponsors can choose if they want to use a traditional 510(k) review or an alternative, Shuren said during the webinar.
“If we build the things that better fit those technologies, particularly around digital health, and in particular AI/ML, I think folks will come and we can have paradigms that are better tailored to this iterative nature of technology, better support innovation and I think at the same time better assure the safety and effectiveness of devices and allow us to learn about the true performance in real world practice,” he added.
Another big topic that’s been on CDRH’s plate is the precertification (pre-cert) program which was developed by Bakul Patel, then-director of digital health. The program is meant to be a new pathway for certain medical software that would allow products to come to market faster and continue to update themselves, based on factors including the agency’s level of trust for specific manufacturers. While the pilot was launched in 2018, the agency has not provided much information on how it is going.
While Shuren didn’t specifically address the status of the pre-cert program, he did say that the agency learned a lot from the pilot program that it can incorporate into its operations.
“While our work was focused on unique considerations of AI/ML-enabled devices, many of the lessons learned and some of the regulatory mechanisms may be applicable more broadly to other medical devices,” he said.
More specifically he said certain considerations related to AI/ML such as transparency, health equity, real-world performance monitoring, change control plans, and how to communicate with users may be generalized more broadly to other medical devices.


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