Regulatory Challenges in Getting Total Disc Replacements Onto the Market in an Era of Increased Food and Drug Administration Scrutiny

The growing list of total disc replacements attempts to give options and variability to surgeons while treating degenerative disc disease. However, despite surgeon and patient interest, their path to market has been hindered. Although several variables affect device commercialization, regulatory hurdles have routinely been the focus. In response to device designs outpacing clinically relevant means to assess risks, Food and Drug Administration has resorted to prospective randomized clinical data to evaluate these devices. With road maps essentially laid out by previous approvals, the ever-changing priorities at the Food and Drug Administration continue to make the pathway for getting a new total disc replacement to market bumpier and bumpier.