A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The Chinese Department of Health has issued a field safety notice for Terumo Cardiovascular Systems’ Terumo CDI Blood Parameter Monitoring System 500 due to a faulty contact between the power cables and the sharp edge of the chassis that can potentially damage the cables’ insulation, resulting in an electrical short.