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The lightweight sensors are “lightweight and have a flat, soft cable with smooth edges, so that they lie comfortable on a patient’s hand or foot,” the Switzerland-based manufacturer said. Read More
MDR reports often “describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” said CDRH Director Jeff Shuren. Read More
The FDA said a “least burdensome” approach should be applied throughout the medical device product lifecycle, rather than just in premarket regulatory decisions. Read More
The December 2017 guidance clarifies that the de novo classification process is not the only mechanism available for classifying a new accessory type. Read More