Since 1995, FDA has received 300 submissions for drugs and biological products with AI components and more than 700 submissions for AI-enabled devices, according to FDA Commissioner Robert Califf, MD, in a recent FDA Voices article. These submissions involve integrating AI in various contexts, including drug discovery and repurposing, enhancing clinical trial design elements, dose optimization, endpoint/biomarker assessment, and postmarket surveillance. The Discussion Paper is the agency’s most recent publication on AI and medical products since it announced its intent to publish discussion papers at last year’s virtual public workshop on the “Application of Artificial Intelligence and Machine Learning for Precision Medicine”, which we summarized online here. Previous agency publications include discussion papers on AI in drug development and advanced manufacturing, which we discussed online here.
We anticipate that the various Centers will continue to issue guidance as technology evolves, but stakeholders engaged in developing innovative medical products that use AI are reminded to take time now to understand and prepare for FDA’s risk-based regulatory approach for AI management…
