Zdrowie i gospodarka · 06/09/2000
Draft Guidance for Industry; Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry entitled "Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief." Elsewhere in this issue of the Federal Register, FDA is issuing a notice of a panel recommendation to reclassify totally implanted spinal cord stimulators from class III (premarket approval) to class II (special controls). If this device is reclassified, this draft guidance document will serve as the special control for the reclassified device. This guidance is neither final nor in effect at this time.