FDA Classifies Ingestible Gastrointestinal Blood Detection Capsule as a Class II Medical Device
The FDA has classified the ingestible gastrointestinal blood detection capsule as a Class II medical device, establishing special controls to support the safety and effectiveness of this innovative diagnostic technology.
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.
Health Canada Updates Guidance for Private Label Medical Device Licence Applications
Health Canada has updated its guidance for Class II, III, and IV private label medical device licence applications. Learn what manufacturers need to know about REP submissions, MDSAP requirements, documentation expectations, and compliance implications.