In Brief: Penile rigidity implant downclassification
This article was originally published in The Gray Sheet
Executive Summary
Penile rigidity implant downclassification: FDA publishes proposed rule in Dec. 16 Federal Register to downclassify the preamendment Class III devices to Class II. Comments are due by March 16. A December 1996 510(k) guidance document, a revised draft of which was released by FDA in January, would serve as a special control ("The Gray Sheet" Feb. 3, p. 12). FDA is proposing the downclassification based on data it received from the Health Industry Manufacturers Association and Mentor Corp. under a Sec. 515(i) order calling for safety and effectiveness data...