US FDA Mandates Pre-Clearance Inspections For Devices Sterilized By Novel Techniques
This article was originally published in SRA
Executive Summary
Sponsors of sterile medical devices who use novel techniques to sterilize their products - such as, vaporized peracetic acid, high intensity light, microwave radiation, sound waves and ultraviolet light - will soon be subject to mandatory manufacturing site inspection by the US Food and Drug Administration before their pre-market notification, or 510(k), submission can be cleared1,2.