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FDA releases draft guidance on non-spinal metallic bone screw performance criteria
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The FDA published a draft guidance document that provides performance criteria for non-spinal metallic bone screws and associated washers intended for orthopedic non-spinal fracture fixation, osteotomy or small joint fusion, or arthrodesis being submitted through the safety and performance-based pathway.
According to the draft guidance document, cancellous screws, cortical screws, cannulated screws, fully threaded screws and partially threaded screws are all included within the scope of the guidance. 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 device to demonstrate substantially equivalent performance characteristics. The FDA requests that torsional strength and driving torque mechanical testing be performed in conformance with the currently recognized version of the standard specification and test methods for metallic medical bone screw. Reports for mechanical testing should be provided as specified in the relevant reporting sections of the standard specification and test methods for metallic medical bone screw, as well as to a declaration of conformity to the consensus standard, according to the document. The document also noted attachment A of the Center for Devices and Radiological Health Biocompatibility Guidance should be included to identify biocompatibility end points and evaluation.
Individuals who want to submit comments and suggestions regarding the draft document should do so within 90 days of publication of the notice in the Federal Register.
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