The FDA requires pedicle screw-based stabilization system manufacturers to provide clinical data showing their devices’ efficacy and safety. These regulations are problematic for some companies because such data was not required with the device’s original 510(k) or because the device is offlabel. For other companies, performing the clinical trial exceeds financial capabilities.
If manufacturers cannot produce the clinical data, the FDA may recommend against product approval. As a result, surgeons are often less inclined to use the product.
Read the Millennium Research Group news release on the FDA crackdown.
Read other Becker’s coverage on FDA orders.
FDA Launches New Initiative to Address Infusion Pump Safety Issues
FDA Orders Recall of Baxter’s Colleague Volumetric Infusion Pumps
FDA May Toughen Medical Device Approval Process
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