Artificial intelligence (AI) holds immense potential to revolutionize healthcare, offering advancements in medical product development, improving patient care, and augmenting the capabilities of health care practitioners. With a shared commitment toward fostering innovation and upholding quality, safety, and effectiveness, FDA plans to align their efforts to advance the responsible use of AI for medical products. This paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle.
This collaboration involves fostering partnerships with developers, patient groups, academia, and global regulators to ensure a patient-centered regulatory approach, promoting development and adoption of standards, guidelines, and best practices to ensure the quality and reliability of AI technologies, and aiding in continuous evaluation and monitoring of AI technologies in healthcare settings. Additionally, these centers claim to develop clear policies to provide regulatory predictability for AI use, encouraging innovation while maintaining regulatory standards to protect public health.
As the field of AI rapidly evolves, FDA will remain committed to tailoring regulatory approaches to protect patients, healthcare workers, and promote innovation while maintaining open channels for engagement with stakeholders.
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