At a time when therapeutic decisions are based on reasoned burdens of proof, there is strikingly little evidence supporting the use of most bone graft products. The US regulatory framework dictates the level of supporting evidence. The most stringent type of device marketing application required by FDA is pre-market approval (PMA).
A PMA requires extensive pre-clinical and human clinical investigation to provide assurance that the device is safe and effective for its intended use(s). Despite a market that boasts over 300 options, only two (rhBMP-2 and i-FACTOR Bone Graft) have satisfied the highest regulatory requirements for use in spinal fusion and had their Level I data go into publication.
Tired of seeing products with only pre-clinical (animal) data to demonstrate their potential? Most bone grafting technologies are simple osteoconductive scaffolds that are brought to market via a pre-market notification [510(k)] process because the FDA has determined that the new device is substantially equivalent to a device already cleared for the market. In most cases, products cleared by the FDA via the 510(k) process come to market with only pre-clinical data.
Minimally manipulated human tissues (allografts, stem cells) are not subject to FDA scrutiny prior to market release. It is incumbent on the manufacturer to provide reasonable assurance that the tissues have been minimally manipulated and are considered safe for use in the clinical environment; however, no evidence of clinical efficacy is required prior to release to the market.