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FDA classifies in vivo-cured intramedullary fixation rod in class II
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The FDA announced it has classified the in vivo-cured intramedullary fixation rod into class II or special controls, effective June 8, 2018.
“The special controls that apply to the device type are identified in this order and will be part of the codified language for the in vivo-cured intramedullary fixation rod’s classification,” according to final action order in the FDA’s Federal Register.
The FDA decided to classify the device into class II because it would offer assurance that the device is safe and effective. This action will also reportedly optimize patients’ access to beneficial devices by decreasing regulatory burdens.
“Therefore, on Dec. 19, 2017, FDA issued an order to the requester classifying the device into class II,” the action stated. “FDA is codifying the classification of the device by adding 21 CFR 888.3023. We have named the generic type of device in vivo-cured intramedullary fixation rod, and it is identified as a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures.”
According to the final action, the FDA identified risks for this device type, such as adverse tissue reaction; infection; bone fracture; soft tissue damage; pain or function loss; device migration or instability; revision, electric shock or interference with other electrical devices and exothermic reaction; and measures needed to stem these risks.
Among the special controls for the in vivo-cured intramedullary fixation rod are non-clinical performance testing to show the device performs under the anticipated conditions of use, performance testing that shows it can be inserted and removed, and technological device characterization.
The action noted that the label must include a summary of device technical parameters; information on all device materials; information on procedure, device use and how to remove the device and uncured materials; shelf life; and validated methods to reprocess reusable components and instruments.
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