FDA proposes to classify spinal spheres into class III assignment
Click Here to Manage Email Alerts
The FDA proposed to classify spinal spheres for use in intervertebral fusion procedures into class III assignment.
Currently unclassified, preamendment devices, a release from the FDA noted the decision for spinal spheres to be classified into class III assignment was based on the recommendation from the FDA Orthopaedic and Rehabilitation Devices Panel. Based on the recommendation by the panel and an FDA analysis, the FDA determined that general and special controls are insufficient to provide reasonable assurance of safety and effectiveness for spinal spheres. The FDA also determined spinal spheres present the potential of unreasonable risk of illness or injury, according to the release. In addition to being classified into class III, the FDA also proposed requiring premarket approvals for such devices.
If finalized, the proposed rule would establish the identification and classification for spinal spheres. Individuals may submit either electronic or written comments on the proposed rule by March 15, 2022.
Read more about
Click Here to Manage Email Alerts