This article will examine ways in which the regulatory profession can draw artificial intelligence (AI) to navigate the complexities and fluidity of the global regulatory landscape. Keywords – artificial intelligence, big data, machine learning, SaMD   Introduction Many of the processes within the regulatory landscape entail gathering data, tabulating spreadsheets, collating documents for regulatory submissions, and reviewing dossiers to ensure their quality is c...

Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.     In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enable...

Regulators from the US, Canada, and the United Kingdom unveiled 10 principles to guide the development of good machine learning practice for medical devices.   The principles are meant to be used to drive the adoption of good practices that have been proven in other sectors, to help tailor those practices so that they are applicable to medical technology, and to create new practices specific to the health care sector. The document, which was issued by the US Food and...

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...

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...

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...

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...

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-...

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...