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FDA releases draft guidance on spinal plating system performance criteria
The FDA published a draft guidance document providing performance criteria for anterior cervical or anterior/lateral thoracolumbar spinal plating systems being submitted through the Safety and Performance Based Pathway.
According to the draft guidance, spinal plating systems intended for fixation to vertebral bodies for the purpose of stabilizing the spine for fusion fall within the scope of the document. The document noted devices appropriate for submission through the Safety and Performance Based Pathway do not need to provide direct comparison testing against a legally marketed predicate to demonstrate substantially equivalent performance characteristics. The FDA requests static compression bending, static torsion and dynamic compression bending be performed in conformance with the currently-recognized version of the Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Reports for mechanical testing should be provided as specified in the relevant reporting sections of the Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and the Mechanical Testing section of the FDA’s guidance Spinal System 510(k), as well as to a Declaration of Conformity to the consensus standard, according to the document.
Individuals wishing to submit comments and suggestions regarding the draft document should do so within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
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