External penile rigidity devices
This article was originally published in The Gray Sheet
Executive Summary
Unclassified preamendments products for erectile dysfunction, including constriction rings, vacuum pumps and penile splints, would be made Class II devices under FDA's Jan. 4 proposed rule. The action is in line with a recommendation from the agency's Gastroenterology and Urology Devices Panel in August 1997 ("The Gray Sheet" Aug. 11, 1997, p. 6)