In the November 12, 2014, Federal Register, FDA proposed to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls) via an administrative order, citing FDASIA Section 608(b) as the authority for not proposing such a change through notice and comment rulemaking. In the notice, FDA also proposed to require the filing of a premarket approval application or a notice of completion of a product development protocol for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use. It also proposed to require clarification of the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems.
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