Surgical lamp 510(k) exemption request
This article was originally published in The Gray Sheet
Executive Summary
Getinge/Castle's petition requesting that FDA exempt surgical lamps from premarket notification requirements is denied by the agency in the Dec. 4 Federal Register. FDA made its decision after determining from its medical device reporting database that there is a "risk of over-exposure to ultraviolet light" from the devices, as well a risk of the lamps "falling on surgical personnel during use." With the decision, FDA has denied the first five exemption requests submitted by industry under procedures implemented by FDAMA