Few Regulatory Updates on AI/ML in Medical Devices:
- QV Solutions
- Mar 19
- 1 min read
Despite recent FDA-related uncertainty, international regulatory bodies are actively advancing guidance on AI/ML in medical devices.
Key updates include:
-IMDRF: Published "Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles," establishing a foundation for safe and effective AI-integrated medical devices. [https://lnkd.in/g9gXRn_T]
-Health Canada: Released "Pre-market Guidance for Machine Learning-Enabled Medical Devices," providing manufacturers with specific submission requirements for MLMDs (Classes II, III, and IV). [https://lnkd.in/giaJZfTX]
-FDA: Issued draft guidance, "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations," outlining their expectations for development and submission of AI-enabled device software. [https://lnkd.in/gKP5Z2eW]
Quick comparison of these docs:
Comments