The Food and Drug Administration (FDA) has announced a significant development in the regulation of artificial intelligence (AI) in healthcare, seeking to provide key guidance for developers of AI-enabled medical devices. On Monday, the agency revealed that it is issuing draft guidance intended to assist these developers throughout the life cycle of their products. Troy Tazbaz, director of the FDA’s digital health centre of excellence, stated that if finalised, this would represent the first comprehensive set of recommendations from the agency pertaining to AI-enabled devices from inception to market and beyond.
The draft guidance arrives at a time when the pace of AI development in healthcare is outstripping the current regulatory frameworks. According to Tazbaz, the FDA has authorised over 1,000 AI-enabled medical devices through various pre-market pathways. The agency has brought together insights from these previously authorised devices to inform its guidance, which aims to offer a clear and accessible framework for maintaining and documenting AI-enabled medical technology. The guidance will address critical considerations such as transparency and the mitigation of bias throughout the total product life cycle. The FDA has invited public commentary on the draft until April 7.
Meanwhile, the FDA is also making strides in the drug development sector by issuing its inaugural draft guidance on the application of AI in this field. The surge in machine learning innovations over nearly a decade has led to a marked increase in drug regulatory submissions incorporating AI, with over 500 submissions since 2016, predominantly in oncology, neurology, and gastroenterology. Tala Fakhouri, who co-leads the FDA’s Centre for Drug Evaluation and Research’s AI Council, highlighted the exponential growth of such submissions, indicating a significant shift in regulatory bodies' engagement with AI technologies used in drug development.
This guidance follows a reflection paper from the European Medicines Agency, which addressed the use of AI in the drug product lifecycle and was finalised in September 2024. Xiaoyan Wang, senior vice president of life sciences solutions at clinical data company IMO Health, pointed out that "regulatory clarity is one of the top three barriers of adopting AI in this space". The FDA's draft guidance seeks to provide that much-needed clarity for industry stakeholders, facilitating the continued advancement of AI in drug development while ensuring compliance with regulatory standards.
Source: Noah Wire Services