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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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.