TMJ premarket applications based on historically controlled studies urged by TMJ Implants, Inc..
This article was originally published in The Gray Sheet
Executive Summary
USE OF NON-RANDOMIZED, HISTORICALLY CONTROLLED STUDIES IN TMJ PMA submissions is urged by temporomandibular joint implant manufacturer TMJ Implants, Inc. in recent comments to FDA. Responding to FDA's July proposed call for premarket approval applications for partial and total TMJ prostheses, TMJ Implants notes that the preamendments devices have been marketed for over 30 years and "over this time" have become "an acceptable treatment regimen." Therefore, the firm reasons, a randomized trial with a concurrent control is not feasible since it would be impossible "to ask a physician to randomize a patient to [an alternative] treatment regimen that over time has shown to not be the treatment of choice in treating TMJ disorders."
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