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Nineteen years after issuing final guidance on medical device reporting for manufacturers, the FDA has replaced that document with updated guidance… Read More
Medtronic warned customers in early October of an issue with some of its Model 37751 rechargers for its deep-brain stimulation devices, saying they may become unresponsive and unable to fully recharge the neurostimulator until they are reset. Read More
The International Medical Device Regulators Form has proposed a new system for reporting adverse events related to medical devices that will provide consistency for and reduce the burden on manufacturers. Read More