Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Sleep apnea monitors: Effective Oct. 15, 1sleep apnea monitor final rule creates a separate category for the devices, which are currently classified as frequency breathing monitors. Manufacturers seeking clearance for sleep apnea monitors should demonstrate conformance to the sleep apnea monitor special controls guidance accompanying the July 17 final rule, or prove that the firm has taken equivalent measures to provide reasonable assurance of safety and effectiveness, FDA notes...