FDA tracking reg letter
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center will send a letter to manufacturers of penile implants and partial and total temporomandibular joints in the next several weeks informing the firms of their responsibilities under device tracking regulations due to go into effect in August. Penile and TMJ implants will be added to the list of devices that must be tracked in an upcoming revision to the final rule, according to FDAers ("The Gray Sheet" Dec. 14, 1992, p. 25).