FDA panel discusses guidance document for ventilators
This article was originally published in Clinica
The classification of ventilators into critical care (MNT) and noncritical care (MNS) devices was a major topic for discussion by the US FDA's Anesthesiology and Respiratory Therapy Devices Advisory Panel on September 8th. The panel reviewed a draft guidance document designed to help manufacturers to prepare 510(k) submissions for common conventional positive pressure ventilators. Topics covered include testing, electromagnetic compatibility, reusable parts, disinfection, biocompatibility and labelling.