External penile rigidity device OTC sales via 510(k) sanctioned in revised FDA policy.
This article was originally published in The Gray Sheet
Executive Summary
EXTERNAL PENILE RIGIDITY DEVICES: OVER-THE-COUNTER SALES for use in treating or managing erectile dysfunction require 510(k) review and adequate labeling for the layperson, FDA says in a Sept. 10 interim policy on constriction rings, vacuum erection systems and penile splint products that allows OTC sales of the devices for the first time. The devices previously were made available for medical use only with a physician prescription.