ABSTRACT
The Food and Drug Administration (FDA) is the gatekeeper for the clinical evaluation and ultimate marketing of all products classified as medical devices. Bone graft substitute (also referred to as bone void filler) products, regardless of the medical indication, specified intended use, and composition of the product, are medical devices. As described below, some may be considered Combination Products, but if the primary intended purpose (primary mode of action [PMOA]) is to serve as a graft filler for osteoconductive purposes, under the current regulatory approach, the product will be considered to have a device PMOA and it will be regulated primarily as a device.
