• Regulatory NewsRegulatory News

    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
  • 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

    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...
  • Regulatory NewsRegulatory News

    FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

    The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical device (SaMD) technologies that are powered by artificial intelligence (AI) and machine learning (ML). The agency said it may conduct a “focused review” in cases where proposed SaMD pre-specifications (SPS) and algorithm change protocols (ACP) “can be refined based on the real-...
  • Regulatory NewsRegulatory News

    How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives

    The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent. The reversal of the lower court decision could mean a loss of patent protection and the launch of new Safyral and Beyaz generics before the patent expires in April 2020. The story and patent claim on the contraceptives...