Shuren: Lawmakers should enable voluntary alternative pathway, international reliance
TORONTO – The former director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said he hopes lawmakers pass legislation to allow the agency to develop a voluntary alternative pathway (VAP) and enable greater international reliance to better meet the needs of new technologies.Jeff Shuren, the former longtime CDRH director, who currently serves in the Office of the Commissioner, participated in multiple panels at the 2024 Medtech Conference, during which he argued that FDA’s current regulatory system for medical devices was not built to handle newer technologies such as artificial intelligence/machine learning (AI/ML).
“The US regulatory system, the law that's in place, it’s almost 50 years old, and I've said repeatedly that it was literally designed for my grandmother's technology,” he told Focus. “It's been modified a little bit over the years, but it is, in many cases, not fit for purpose for a lot of modern technologies, and you've just got to fix it.”
The current regulatory paradigm for medical device regulatory oversight in the US was established by the Medical Device Amendments of 1976, which Shuren said is not well suited to today’s cutting-edge technologies, and the law should change to better accommodate them. He noted that products coming to market that feature newer technologies, such as AI/ML, tend to be tailored to fit within the confines of the law.
“There's a lot of modern technologies that don't meet well in the paradigm,” said Shuren. “We have talked about a voluntary alternative pathway that gives us the flexibility to build the pathway around the technology rather than trying to shoehorn a technology into a pathway that's not fit for purpose but keep the US standard to market of reasonable assurance of safety and effectiveness."
Shuren and other FDA officials have advocated for VAP in recent years, arguing that it would give the agency more flexibility in authorizing devices without compromising its public health mission. However, despite announcing plans for a guidance on such a pathway in 2017, a formal proposal for the pathway has yet to materialize. (RELATED: Shuren: Getting QMSR out by year’s end a ‘high priority’, Regulatory Focus 23 May 2023)
"We need different frameworks,” said Shuren. “Many of the things when we deal with AI, we've got to make sure we're monitoring and learning in the postmarket setting, a lot of it has to be handled there."
Shuren also noted that FDA needs additional authorities to enable it to leverage the expertise and decisions of other international regulators to allow products on the market that have been vetted by comparable authorities.
“Can we really do reliance appropriately under current authorities?” Shuren asked. “That I think is going to be a challenge because typically you need to line it up just right.”
Shuren pointed to the Medical Devices Single Audit Program (MDSAP), which allows for a company to undergo a single audit, conducted by a recognized auditing organization, to satisfy regulatory requirements in participating jurisdictions, as an example of international reliance. Currently, regulators in Australia, Brazil, Canada, Japan, and the US are MDSAP members, with regulators from several other jurisdictions participating as observers and affiliates.
However, when it comes to authorizing products, he said it would require changes to the law to enable FDA to rely on other regulators’ decisions. He gave the example of a product coming in for premarket review that doesn’t follow the analysis approach for a 510(k). “It’s not going to fit under that pathway, but the science may be the good science that we need, and it may be truly fit-for-purpose, but from a legal standpoint we couldn’t do it.”
“Reliance for developing countries is one thing, but for developed countries, we may need some help from our legislators to make it a reality,” he added.
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