FDA Publishes New Guidelines for the Use of Artificial Intelligence in Medical Products
The US Food and Drug Administration (FDA) has published a new reference document on the application of Artificial Intelligence (AI) in the life cycle of medical products. The aim is to establish a solid regulatory framework that promotes responsible innovation, ensuring that technological advances in medical devices, medicines and biological products are developed and used safely, effectively and ethically.
The FDA has identified four priority areas for regulating the use of AI in healthcare:
Collaboration to Protect Public Health - The FDA will strengthen joint work with manufacturers, researchers, international regulatory bodies and health professionals to promote transparent and reliable use of AI. This includes measures to reduce algorithmic bias, ensure the explainability of models and improve the cybersecurity of devices.
Supporting Innovation and Regulatory Development - The agency will develop specific guidelines for the evaluation and monitoring of AI algorithms, ensuring that systems can adapt to changing clinical conditions without compromising patient safety. The FDA will also work on regulating AI applied to drug discovery and manufacturing.
Definition of Standards and Best Practices - To ensure the integrity of AI-based medical products, the FDA will establish standards and methodologies to evaluate the safety, efficacy and quality of devices. In addition, guidelines will be created for the AI lifecycle, addressing everything from initial development to ongoing maintenance in real clinical environments.
Continuous Monitoring of AI Performance - The FDA will support pilot projects to evaluate how AI systems perform over time and how they may impact the safety and effectiveness of medical products. This monitoring will ensure that AI-based devices maintain reliable performance and are continuously improved based on new evidence.
The publication of these guidelines reflects the growing importance of Artificial Intelligence in healthcare and the need for regulations that balance technological innovation and patient safety. The FDA reinforces its commitment to supporting the development of advanced medical solutions, ensuring that AI is used ethically and effectively in the healthcare sector.
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