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If an accessory request included in a cleared or approved submission is denied, the new accessory type “will be considered to be in the same classification… Read More
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