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Hand Biomechanics Lab, a manufacturer of bone fixation fastener systems in Sacramento, California, was hit with an FDA warning letter for failing to submit MDRs and for GMP nonconformities. Read More
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
Evidence introduced by Cook to challenge the BSI patent had initially convinced the board of reasonable likelihood for the first 19 claims to be unpatentable. 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