• Regulatory NewsRegulatory News

    ICMRA: Address artificial intelligence challenges with permanent working group

    The rapid expansion and evolution of artificial intelligence (AI) will challenge the current regulatory pharmaceutical and device, according to a new horizon-scanning report from an international consortium of regulators. The ad hoc group recommends a permanent working group to stay abreast of the regulation of AI in the development and assessment of medicinal products.   A 6 August report from the International Coalition of Medicines Regulatory Authorities (ICMRA) d...
  • RF Quarterly

    RF Quarterly, June 2021: Artificial intelligence in global regulatory practice

    Welcome to the summer issue of RF Quarterly in which international experts from the UK, EU, Saudi Arabia, Hong Kong, and the US have come together to examine and dissect the role of artificial intelligence (AI) in healthcare and its impact on global regulatory practice.   Advances in AI technologies are transforming healthcare delivery and hold promise for improving patient outcomes. However, these complex technologies have introduced new challenges, especially aroun...
  • RF Quarterly

    Artificial intelligence: Characteristics, regulatory compliance, and legislation

    This article provides an introduction to artificial intelligence (AI), its characteristics, and how those characteristics affect regulatory compliance. It also examines efforts to regulate the ethical aspects of AI in the EU, future legislative initiatives that may affect AI in medical devices, and the crucial role standards play in supporting legislation.*   Introduction Although different people may understand artificial intelligence (AI) differently, it has been...
  • RF Quarterly

    Modernizing medical devices regulation for AI and ML: GHWP efforts

    The recent progress of artificial intelligence (AI) technologies has had a pivotal impact on the healthcare system. Medical device manufacturers use these technologies to develop new and innovative products for better health outcomes. However, these technologies have introduced new challenges to the medical field. There is a need to have a novel medical device regulatory framework that addresses these challenges. This article addresses the impact of AI on the medical devic...
  • RF Quarterly

    Regulatory update for SaMD and AI product approvals in China

    This article outlines the status of regulation for software as medical device (SaMD) in China, with particular focus on medical software using artificial intelligence (AI) technology. The market approval pathways are reviewed, and key sticking points discussed. Recent regulatory updates in this fast-moving area are presented, together with various product approval examples.   China’s medical software regulatory framework The term “medical device” is defined widely ...
  • RF Quarterly

    Enabling the digital transformation of industry: The roles of AI, big data, analytics, and related data ecosystem

    This article outlines the work of SC 42, the technical subcommittee for artificial intelligence (AI) of the ISO/IEC’s joint technical committee 1, which aims to accelerate adoption of the standards while simultaneously addressing emerging issues to enable successful digitalization of sectors.   Introduction and overview The digital transformation of industry promises to revolutionize how we live, work, and play, unlocking the vast potential of new use cases and ap...
  • RF Quarterly

    Synthetic data and the innovation, assessment, and regulation of AI medical devices

    Synthetic data are artificial data that mimic the properties of and relationships in real data. They show promise for facilitating data access, validation, and benchmarking, addressing missing data and under-sampling, sample boosting, and the creation of control arms in clinical trials. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is using its current research into the development of high-fidelity synthetic data to develop its regulatory position on ar...
  • Regulatory NewsRegulatory News

    Euro Convergence: Market access pathways for AI now visible

    The pathways companies will use to bring artificial intelligence or machine learning (AI/ML) medical devices and diagnostics to market in the future are now becoming clear, Loganathan Kumarasamy, head of US compliance services at Zifo Technologies, said at RAPS Euro Convergence 2021.   Devices and diagnostics that make use of AI and ML need regulation specific to the field, Kumarasamy said, pointing out that software in medical devices has long been used safely under e...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
  • Regulatory NewsRegulatory News

    FDA’s AI/ML action plan includes ‘tailored’ regulatory framework for SaMD

    The US Food and Drug Administration has released a five-part action plan for its oversight of artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) based on feedback from developers and manufacturers on an April 2019 discussion paper.   Top of the action-plan list is the agency’s intention to develop a “tailored” regulatory framework for the medical software by issuing draft guidance on the Predetermined Change Control Plan outl...
  • Regulatory NewsRegulatory News

    Drug Regulators Look to Harmonize How They Tackle Innovation

    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI). The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regu...
  • Device Groups Say FDA Communication Guidance Gets Additional Information Letters Wrong

    Several entities within the medical device industry are calling attention to a provision within a recent draft guidance published by the US Food and Drug Administration (FDA) that they say offers little in the way of clarification and could potentially be a sticking point during complicated and contested review proceedings. Background In March 2013, FDA released a long-awaited guidance entitled Types of Communication During the Review of Medical Device Submissions . T...