• 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

    FDA to Device Industry: Teach us More About Diagnostics and Sequencing

    The US Food and Drug Administration's (FDA) medical device regulators are once again preparing to expand a program they use to learn about cutting-edge and essential medical technologies, this time with a particular focus on in vitro diagnostics and next generation sequencing (NGS) technology. Background The program FDA has proposed to extend is known as the Experiential Learning Program (ELP), and was first proposed in September 2011 by FDA's medical device regulatory ...
  • Regulatory NewsRegulatory News

    FDA Wants its Regulators to Learn More About 3D Printing, Other Device Topics

    The US Food and Drug Administration (FDA) announced this week that it plans to expand a program it uses to better understand the real-world challenges of the medical device industry it regulates. The ELP Program FDA's Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort to reform the Center for Devices and Radiological Health (CDRH) in light of criticism that the center was too out of touch with challenges faced by device manu...
  • FDA Extends Program in Hopes of Helping its Regulators Learn More About the Device Industry

    The US Food and Drug Administration (FDA) is once again extending a program intended to help its medical device review staff to better understand the regulatory process from the perspective of the industry it regulates. The ELP Program The program, known as the Experiential Learning Program (ELP) was announced in September 2011 as part of an ongoing effort for reforms at the Center for Devices and Radiological Health (CDRH) intended to accommodate criticism from industr...