Zdrowie i gospodarka · 4.10.1995
Orthopedic Devices: Classification, Reclassification, and Codification of Pedicle Screw Spinal Systems
The Food and Drug Administration (FDA) is proposing to classify certain unclassified preamendments pedicle screw spinal systems into class II (special controls), and to reclassify certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is also issuing for public comment the recommendations of the Orthopedic and Rehabilitation Devices Panel (the Panel) concerning the classification of pedicle screw spinal systems, and the agency's tentative findings on the Panel's recommendations. After considering any public comments on the Panel's recommendations and FDA's proposed classification, in addition to any other relevant information that bears on this action, FDA will publish a final regulation classifying the device. This action is being taken because the agency believes that there is sufficient information to establish special controls that will provide reasonable assurance of its safety and effectiveness.