IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.
FDA-Advancing Real World Evidence Program
On October 2022, the U.S. Food and Drug Administration is announcing the Advancing Real-World Evidence (RWE) Program
FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.