TMJ Implants warning letter
This article was originally published in The Gray Sheet
Executive Summary
FDA cites premarket violations observed during an inspection of the oral and maxillofacial device firm's Web site in a Dec. 20 warning letter. Based on the Sept. 5 inspection, FDA maintains that TMJ Implants is promoting hemi and full mandibles without an approved PMA, 510(k) or investigational device exemption. Separately, the firm is embroiled in an administrative dispute with the agency over medical device reporting issues outlined in a February 2004 warning letter. The dispute is slated for a hearing in April (1"The Gray Sheet" Jan. 1, 2007, p. 4)...