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Traditional study designs are the most suitable way to demonstrate performance of liquid chromatography-mass spectrometry in vitro diagnostic devices, despite their complex nature. Read More
With mobile medical apps to track fitness and monitor other vital signs, developers have many questions — and seemingly few answers — on how their products will be regulated. Read More
CDRH soon will have three medical device divisions that are responsible for monitoring and managing the entire establishment inventory both domestically and globally, under its new program alignment. Read More
The UK’s Medicines and Healthcare products Regulatory Agency plans on taking a global leadership role in surveillance and regulation of devices. Read More
Invibio — which makes a polymer for medical implants — has settled with the FTC for allegedly using anticompetitive tactics to keep potential rivals from gaining customers. Read More