Regulacje i polityka gospodarcza · 15/12/2021

FDA Proposes New Requirements for Spinal Spheres Used in Intervertebral Fusion Procedures

The US Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) for spinal spheres used in intervertebral fusion procedures, a type of unclassified, preamendments device, in an effort to reduce the risk of illness or injury associated with its use.