The medtech lobby group AdvaMed has asked the US Food and Drug Administration (FDA) to make changes to its recent guidance on orthopedic non-spinal bone fixation devices to clarify the agency’s position and avoid potentially conflicting requirements.
In March, FDA published a draft guidance entitled Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions. The document explains how sponsors should describe the indications for use for their devices, how to compare the devices to predicate devices, labeling requirements, sterility testing and more. The public comment period for the guidance closed on 30 May and AdvaMed was the only organization to comment on the guidance.
The guidance states that it does not specifically address non-spinal bone plate, screw, and washer devices with certain characteristics such as nitinol and coated devices, as well as those with surface modifications. The agency also said the guidance does not apply to devices with complex geometries and those with unique geometric features…
