AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance

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In March, FDA published a draft guidance entitled Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions.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.

In its comments, AdvaMed said the agency should consolidate the terms to devices with unique or complex geometries in order provide more clarity.

FDA lists specific devices that are not covered under the guidance including bone plates and screws that are intended for mandibular, maxillofacial, cranial and orbital fracture fixation; those intended for use in the spine and suture anchors; and fixation components that are part of a bone anchor tightrope. AdvaMed, however, said that the language is confusing and isn’t representative of clinical practice.

The “language does not make sense as written,” said the group. “Bone plates and screws are not intended for use in suture anchors.

AdvaMed also argues that some of the language in the draft guidance is inconsistent with other FDA guidances and positions, which may cause confusion for sponsors of orthopedic non-spinal devices.

For instance, the guidance states that sponsors that are seeking an indication for use in osteopenic bone should compare their device to devices currently marketed for use in the same anatomical location with similar indications. The agency goes on to state that indications for osteoporotic bones or “poor bone quality," defined in certain cases as lower bone mineral density (BMD), may require simulated performance data.

AdvaMed points out that poor bone quality is also measured in terms of mechanical strength, which may be confusing to sponsors.

When providing data on screws, FDA said sponsors can use engineering analysis in lieu of bench testing to support substantial equivalence to the predicate device. AdvaMed has asked the agency to consider referring to a previously published screw final guidance instead of repeating the requirement in the new guidance.

“Much of the information is redundant to the screw guidance,” said the group. “Including the same information in two separate guidances may result in inconsistencies in FDA’s overall communication to manufacturers.”
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AdvaMed calls for changes to FDA’s non-spinal bone fixation device guidance

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