Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “UK Seeks Overhaul of AI, Software as a Medical Device Regs,” by Greg Slabodkin.

Following is an excerpt:

With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the country's regulations for software and AI as a medical device without the burden of accommodating the regulatory approaches of EU members. …

AI and SaMD technologies have the potential for better diagnosing and treating a wide variety of diseases, but FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device. The agency is considering a total product lifecycle-based regulatory framework for adaptive or continuously learning algorithms.

Thompson points out that MHRA is "basically a small step earlier" than the FDA's AI/ML-based SaMD action plan issued in January, which calls for further developing a proposed regulatory framework by issuing draft guidance.

"It's a step earlier because it's broader — it covers a wide variety of regulatory issues for all software as a medical device, not just AI," according to Thompson. "But overall, both governments are trying to do the same thing: outline a path forward for modernizing medical device regulation to address the unique aspects of AI." 

MHRA has working groups developing policy on the different elements articulated in its Software and AI as a Medical Device Change Programme. 

"The U.K. has said that it's work products in each of the different streams will trickle out between fall of 2021 and summer of 2023. It doesn't appear that FDA is frankly moving any faster," Thompson said. "The U.K. envisions releasing intermediate documents of course. They will be releasing more detailed timelines of key deliverables and opportunities for public input." …

While Thompson acknowledges FDA plans to publish a draft guidance this year, he said there is no indication so far as to when. The next step, according to Thompson, is the virtual public workshop on the transparency of AI/ML-enabled medical devices scheduled for October 14, which was called for in the FDA's January action plan.

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