FDA Orders 12 Firms To Collect Data On Dynamic Spine Stabilization Devices
This article was originally published in The Gray Sheet
FDA is ordering 12 spine device manufacturers to begin collecting post-market data on how well their devices fare in doing what they are 510(k)-cleared to do: support spinal fusion procedures
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US FDA has completed a long-running effort to reclassify pedicle screw systems, which are widely used devices for spine fusion procedures. The final policy: all pedicle screws intended as an adjunct to fusion surgery are class II/special controls devices, but "semi-rigid" systems will require clinical data to support 510(k) clearance while more traditional, rigid systems will not.
The agency proposes to maintain 510(k) standards for rigid pedicle screw systems but wants dynamic spine stabilization devices, designed to provide more motion and flexibility, to go the PMA route.
FDA is emphasizing the need for “early and ongoing” interaction between regulators and device companies targeted by the agency in Section 522 post-market surveillance orders in a draft guidance issued Aug. 16.