Technically OTC devices
This article was originally published in The Tan Sheet
Executive Summary
Joint meeting of FDA's Ear, Nose & Throat and Dental Devices Panels will convene Oct. 6 to discuss data and labeling requirements for over-the-counter obstructive sleep apnea products and other issues related to OTC and prescription OSA device use. Separately, Philips Medical's HeartStart Home defibrillator is deemed safe enough to justify over-the-counter clearance by members of FDA's Circulatory System Devices Panel at a July 29 meeting. Concerns were raised, however, about use on patients with an implanted cardioverter defibrillator and pediatric use...