UK seeks overhaul of AI, software as a medical device regs
Summary
• MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide a regulatory framework that will ensure "the U.K. is the home of responsible innovation." With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the countrys 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. MHRA has invited members of the public to provide their views on possible changes to the overall regulatory framework for medical devices in the U.K., not just AI and SaMD, with the goal of developing a "world-leading future regime" for medtech that prioritizes patient safety while fostering innovation. Jeff Shuren, director of FDAs Center for Devices and Radiological Health, told the Food & Drug Law Institute conference in May the agencys January action plan for establishing a regulatory approach to SaMD puts it on schedule for proposed guidance for an AI/ML framework in 2021.