Virtual Public Workshop – Spinal Device Clinical Review

The Food and Drug Administration (FDA) is announcing a virtual public workshop entitled “Spinal Device Clinical Review.” This workshop is intended to enhance public understanding of FDA’s approach to clinical review of spinal devices falling under 21 CFR Part 888. The purpose of the workshop is to provide information to our stakeholders, including members of the orthopedic community, device manufacturers, regulatory affairs professionals, clinicians, patients and the general public, regarding FDA regulations, guidances and regulatory pathways related to spinal device clinical review.