FDA Publishes Discussion Paper on Regulation of Generative AI-Enabled Medical Devices
FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.
IMDRF Publishes Final Document on Predetermined Change Control Plans for Medical Device Software
IMDRF has published final principles on Predetermined Change Control Plans for medical device software, covering PCCP elements, risk-based change control, impact assessment, benefits and challenges.
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MHRA Releases AI Airlock Sandbox Phase 2 Programme Report
MHRA releases its AI Airlock Sandbox Phase 2 report, detailing regulatory insights on AI validation, PCCPs, generative AI, and real-world PMS.
FDA Classifies Radiological Machine Learning-Based Quantitative Imaging Software with Predetermined Change Control Plans as Class II Devices
The FDA has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, establishing special controls to support the safe development and regulatory oversight of AI-enabled imaging software.
MHRA Publishes AI Airlock Phase 2 Report on Regulatory Challenges for AI Medical Devices
The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.