FDA Moving Forward On Implantable Spinal Stimulation Downclassification
This article was originally published in The Gray Sheet
Executive Summary
While FDA views a guidance for implantable spinal cord stimulator (SCS) 510(k) submissions as an appropriate special control, the agency has decided to forego other suggestions made by its Neurological Devices Panel in recommending downclassification of the devices from Class III to Class II.
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